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At Ethicon we are committed to addressing the world’s most pressing healthcare issues by advancing technologies, research and training, and
working with healthcare providers across a diverse set of specialties to help improve outcomes and expand access to quality surgical care.
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PN120 120mm 12
PN150 150mm 12
UV120 120mm 12
3013SP 3 grams 5
SURGICEL™ Endoscopic Applicator
Product Code Size EA/BX
1978 1.0g 6
1979 1.0g 6
HARMONIC® Blades
Product Code Shaft Diameter Shaft Length Tip EA/BX
HARMONIC® Accessories
Product Code Description EA/BX
HARMONIC®
HGA11 HP054 and HPBLUE hand pieces 1
connector
Output
GEN11VK GEN11 1
verification key
1-Year extended
GEN11WAR1 1
warranty
2-Year extended
GEN11WAR2 1
warranty
0600 L-Wire 6
0618 Spatula 6
0620 L-Hook 6
0621 J-Hook 6
MEGADYNE™ Reusable
Foot Control Cord Product Code Description Length EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II System Product Code Grip Control EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II Electrode Shafts Product Code Shaft Diameter Shaft Length Electrode EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II Tubing Product Code Description EA/BX
ULTRAPRO® Partially
Absorbable Mesh Product Code Description Size EA/BX
ULTRAPRO ADVANCED™
Product Code Description Size EA/BX
ULTRAPRO® Plug
Product Code Description Rim Size Anchor Size EA/BX
ETHICON SECURESTRAP®
Absorbable Strap Fixation Device Product Code Description EA/BX
EL214 Medium 1
EL314 Medium/Large 1
EL414 Large 1
LIGACLIP® Multi-Patient
Single-Clip Applier - Yellow Product Handle Tip Angle
Code Length Color Clip Size Specification EA/BX
Medium/
LT300 Open/endo Green 6 18
Large
PD2MSURG 1
NEUWAVE™ SR Probe
Product Code Length Gauge size EA/BX
NEUWAVE™ PR Probe
Product Code Length Gauge size EA/BX
NEUWAVE™ PR XT Probe
Product Code Length Gauge size EA/BX
NEUWAVE™ LK Probe
Product Code Length Gauge size EA/BX
NEUWAVE™ LK XT Probe
Product Code Length Gauge size EA/BX
NEUWAVE™ LN Probe
Product Code Length Gauge size EA/BX
NEUWAVE™ ARM
Product Code Description EA/BX
NEUWAVE™ ARM 1 with standard 1 inch medical bed rail
ARM1 1
mount
ARM2 NEUWAVE™ ARM 2 with Dovetail bed rail mount 1
Mesentery/
ECR60M Gray 6 2.0mm .75mm 12
thin
Mesentery/
ECR45M Gray 6 2.0mm .75mm 12
thin
PROXIMATE® Reloadable
Staplers (TX) Number Open Closed
Product Cartridge of Staple Tissue Staple Staple Reload Max EA/
Code Color Rows Thickness Height Height Included Firings BX
GYNECARE INTERCEED®
Absorbable Adhesion Barrier Product Code Description EA/BX
GYNECARE INTERCEED® Absorbable Adhesion Barrier, 3"
4350 10
x 4" (7.6cm x 10.2cm)
GYNECARE INTERCEED® Absorbable Adhesion Barrier
4350XL 10
XL, 5" x 6" (12.7cm x 15.2cm)
GYNECARE GYNEMESH® PS
Nonabsorbable PROLENE® Soft Mesh Product Code Description EA/BX
0 Violet 12 23 12 SXPP1A446
CT-2, 1/2 Circle, 26mm
0 Violet 18 45 12 SXPP1A407
CT-2, 1/2 Circle, 26mm
0 Violet 9 23 12 SXPP1A425
CT-1, 1/2 Circle, 36mm
0 Violet 12 30 12 SXPP1A433
CT-1, 1/2 Circle, 36mm
0 Violet 18 45 12 SXPP1A401
CT-1, 1/2 Circle, 36mm
0 Violet 18 45 12 SXPP1A406
CT, 1/2 Circle, 40mm
0 Violet 18 45 12 SXPP1A402
CTX, 1/2 Circle, 48mm
0 Violet 24 60 12 SXPP1A442
CTX, 1/2 Circle, 48mm
1 Violet 6 15 12 SXPP1A420
CT-1, 1/2 Circle, 36mm
1 Violet 12 30 12 SXPP1A435
CT-1, 1/2 Circle, 36mm
1 Violet 18 45 12 SXPP1A404
CT-1, 1/2 Circle, 36mm
1 Violet 24 60 12 SXPP1A443
CT-1, 1/2 Circle, 36mm
1 Violet 18 45 12 SXPP1A405
CT, 1/2 Circle, 40mm
1 Violet 24 60 12 SXPP1A444
CT, 1/2 Circle, 40mm
1 Violet 18 45 12 SXPP1A400
CTX, 1/2 Circle, 48mm
1 Violet 24 60 12 SXPP1A445
CTX, 1/2 Circle, 48mm
1 Violet 18 45 12 SXPP1A201
OS-6, 1/2 Circle, 36mm
1 Violet 24 60 12 SXPP1A203
OS-6, 1/2 Circle, 36mm
1 Violet 18 45 12 SXPP1A300
CTXB, 1/2 Circle, 48mm
0 Violet 6 15 12 SXPP1B406
CT-1, 1/2 Circle, 36mm
0 Violet 12 30 12 SXPP1B450
CT-1, 1/2 Circle, 36mm
0 Violet 12 30 12 SXPP1B405
CT-2, 1/2 Circle, 26mm
1 Violet 14 x 14 36 x 36 12 SXPD2B202
OS-8, OS-8, 1/2 Circle
- 1/2 Circle, 36mm,
36mm
1 Violet 14 x 14 36 x 36 12 SXPD2B400
MO-4, MO-4, 1/2 Circle
- 1/2 Circle, 36mm,
36mm
1 Violet 14 x 14 36 x 36 12 SXPD2B405
CTX, CTX, 1/2 Circle
- 1/2 Circle, 48mm,
48mm
Suture
No Needle USP Color Length EA/BX Code
DERMABOND ADVANCED®
Topical Skin Adhesive Adhesive
Product Code Description Volume EA/BX
Unique formulation with an easy-to-use
DNX12 applicator for precise control for wide and 0.7mL 12
fine line applications
Unique formulation with an easy-to-use
DNX6 applicator for precise control for wide and 0.7mL 6
fine line applications
DERMABOND® PRINEO®
Skin Closure System Adhesive
Product Code Description Volume EA/BX
2-octylcyanoacrylate topical skin adhesive
CLR222US applicator. Flexible, self-adhesive polyester 3.8mL 2
mesh
2-octylcyanoacrylate topical skin adhesive
CLR602US applicator. Flexible, self-adhesive polyester 3.8mL 2
mesh tape dispenser
DERMABOND® PRINEO®
Adhesive
Product Code Description Volume EA/BX
ENDOSUTURE ENDO-HOLDER™
Product Code Description EA/BX
Suture Assistant
Product Code Needle Type EA/BX
SW100 N/A 4
Staple Extractor
Product Code Description EA/BX
ENDOPATH® Scissors
Product Code Description EA/BX
ENDOPATH® Graspers
Product Code Description EA/BX
ENDOPATH® Babcocks
Product Code Description EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II System Product Code Grip Control EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II Electrode Shafts Product Code Shaft Diameter Shaft Length Electrode EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II Tubing Product Code Description EA/BX
INDICATIONS
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic
approach) where surgical treatment for vaginal vault prolapse is warranted.
CONTRAINDICATIONS
• ARTISYN™ Y-Shaped Mesh should not be used in infants, children, pregnant women, or in women planning future pregnancies, because the
mesh will not stretch significantly as the patient grows.
• ARTISYN™ Y-Shaped Mesh should not be used in the presence of active or latent infections or cancers of the vagina, cervix, or uterus.
• ARTISYN™ Y-Shaped Mesh must always be separated from the abdominal cavity by peritoneum.
• ARTISYN™ Y-Shaped Mesh must not be used following planned intraoperative or accidental opening of the gastrointestinal tract. Use in these
cases may result in contamination of the mesh, which could lead to infection that may require removal of the mesh.
WARNINGS
• Patients who are on anticoagulation agents and undergoing surgery using ARTISYN™ Y-Shaped Mesh must have their anticoagulation therapy
carefully managed.
• A digital rectal examination may be performed to detect possible rectal perforation.
• Cystoscopy may be performed to confirm bladder integrity or to detect possible bladder or ureteral perforation.
• Postoperatively, the patient should be advised to refrain from intercourse, heavy lifting, and/or exercise (e.g., cycling, jogging) until the
physician determines when it is suitable for the patient to return to her normal activities.
• Use ARTISYN™ Y-Shaped Mesh with care, and with attention to patient anatomy and to proper dissection technique, to avoid damage to
vessels, nerves, bladder, bowel, and vaginal wall.
• The safety and effectiveness of this product has not been validated in clinical trials.
• Reuse of this device (or portions of this device) may create a risk of product degradation and cross-contamination, which may lead to
infection or transmission of bloodborne pathogens to patients and users.
PRECAUTIONS
• Users should be familiar with surgical procedures and techniques involving pelvic floor repair and synthetic meshes before employing
ARTISYN™ Y-Shaped Mesh.
• Avoid placing excessive tension on the mesh implant during placement.
• This product should only be used under the prescription of a licensed healthcare practitioner.
• In patients with compromised immune systems or other conditions that could compromise healing, the risks and benefits should be weighed
carefully.
• Vaginal or urinary tract infection should be treated and alleviated prior to implantation. ADVERSE REACTIONS
• Potential adverse reactions are those typically associated with surgery employing implantable materials of this type, bleeding including
hemorrhage or hematoma, urinary incontinence, urge incontinence, urinary frequency, urinary retention or obstruction, voiding dysfunction,
acute and/or chronic pain, wound dehiscence, nerve damage, recurrent prolapse, inflammation, adhesion formation, fistula formation,
contracture, scarring and mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
• As with any implant, a foreign body response may occur. This response could result in extrusion, erosion, exposure, fistula formation and/or
inflammation.
• Potential adverse reactions are those typically associated with pelvic organ prolapse repair procedures, including pelvic pain or pain with
intercourse, which in some patients may not resolve
• Dissection for pelvic floor repair procedures has the potential to impair normal voiding for a variable length of time.
• Excessive contraction or shrinkage of the tissue surrounding the mesh, vaginal scarring, tightening and/or shortening may occur.
• As with all surgical procedures, there is a risk of infection. As with all foreign bodies, ARTISYN™ Y-Shaped Mesh may potentiate infection.
• Punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, may occur and may require surgical
repair.
Consult your doctor to discuss the potential benefits and risks of your treatment options and whether ARTISYN™ Y-Shaped Mesh is appropriate
for you.
087453-180206
Contraindications
• Do not use to treat bleeding from large defects in arteries or veins.
• Do not apply intravascularly.
• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Adverse Reactions
The adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary
embolism, blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension,
anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid
collection, cardiac failure, operative hemorrhage, and ischemic bowel.
INDICATIONS
The GYNECARE TVT™ Tension-free Support for Incontinence, GYNECARE TVT EXACT® Continence System and GYNECARE TVT™ with
Abdominal Guides Tension-free Support for Incontinence, are intended to be used in women as pubourethral slings for the treatment of stress
urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and
Rigid Catheter Guide are available separately and are intended to facilitate the placement of the GYNECARE TVT Tension-free Support for
Incontinence and GYNECARE TVT with Abdominal Guides.
The GYNECARE TVT Rigid Catheter Guide is available separately and is intended to facilitate the placement of the GYNECARE TVT EXACT.
The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during
the placement of the GYNECARE TVT Device.
GYNECARE TVT™ Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVO® Continence System are intended
to be used in women as sub-urethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or
intrinsic sphincter deficiency.
The GYNECARE TVT Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator
Device and TVTV ABBREVO Continence System.
CONTRAINDICATIONS
• As with any suspension surgery, these procedures should not be performed in pregnant patients.
• Additionally, because the PROLENE Polypropylene Mesh will not stretch significantly, it should not be performed in patients with future growth
potential including women with plans for future pregnancy.
WARNINGS & PRECAUTIONS
• Do not use the GYNECARE TVT Family of Products in patients who are on anti-coagulation therapy.
• Do not use the GYNECARE TVT Family of Products in patients who have a urinary tract infection.
• Bleeding or infection may occur post-operatively.
• Transient leg pain lasting 24-48 hours may occur and can usually be managed with mild analgesics after a GYNECARE TVT Obturator System
or GYNECARE TVT ABBREVO System procedure.
• Since no clinical information is available about pregnancy following sub-urethral sling procedure with the GYNECARE TVT Family of Products,
the patient should be counseled that future pregnancy may negate the effects of the surgical procedure and the patient may again become
incontinent.
• Since no clinical information is available about vaginal delivery following sub-urethral sling procedure with the GYNECARE TVT Family of
Products, in case of pregnancy, delivery via cesarean section should be considered.
• Post-operatively, refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least three to four weeks and to refrain from intercourse
for one month. The patients can usually return to other normal activity after one or two weeks.
• Contact your surgeon immediately if there is burning sensation during urination, unusual bleeding, problems voiding or other problems.
PATIENT FACTORS
Physicians should use their surgical experience and judgment to determine if PROLENE Mesh is appropriate for certain patients. Patient-
specific factors may impair wound healing, which may increase the likelihood of adverse reactions.
ADVERSE REACTIONS
• Punctures or lacerations or injury of vessels, nerves, structures or organs, including the bladder, urethra, or bowel, may occur and may require
surgical repair.
• Improper placement of the GYNECARE TVT Family of Products devices may result in incomplete or no relief from urinary incontinence or
may cause temporary or permanent urinary tract obstruction.
• Transitory local irritation at the wound site may occur.
Consult your doctor to discuss the potential benefits and risks of your treatment options and whether PROLENE mesh is appropriate for you.
026356-200131
INDICATIONS
GYNECARE INTERCEED Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the
incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.
CONTRAINDICATIONS
The use of GYNECARE INTERCEED Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED Adhesion
Barrier is not indicated as a hemostatic agent.
Appropriate means of achieving hemostasis must be employed.
WARNINGS
The safety and effectiveness of GYNECARE INTERCEED Adhesion Barrier in laparoscopic surgery or any procedures
other than open (laparotomy) gynecologic microsurgical procedures have not been established.
Postoperative adhesions may be induced by GYNECARE INTERCEED Adhesion Barrier application if adjacent tissues (eg, ovary and tube) and
structures are coapted or conjoined by the device, or if GYNECARE INTERCEED Adhesion Barrier is folded, wadded or layered. Care must be
taken to apply GYNECARE INTERCEED Adhesion Barrier in single layers, interposed between adjacent anatomic structures at risk for adhesion
formation.
Postoperative adhesions may occur in the presence of GYNECARE INTERCEED Adhesion Barrier if meticulous hemostasis is not achieved
prior to application. As with all foreign substances, GYNECARE INTERCEED Adhesion Barrier should not be placed in a contaminated surgical
site. Potentially contaminated surgical sites include hysterotomy following labor and/or prolonged rupture of membranes. The performance of
GYNECARE INTERCEED Adhesion Barrier at potentially contaminated surgical sites has not been determined.
PRECAUTIONS
Use only a single layer of GYNECARE INTERCEED Adhesion Barrier, since multiple layers of packing or folding will not enhance the adhesion
barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED Adhesion Barrier. Care should be exercised in
applying GYNECARE INTERCEED Adhesion Barrier to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood
prior to completing the procedure, it should be discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesions
formation.
Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if any, of
GYNECARE INTERCEED Adhesion Barrier on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women
who have become pregnant within the first month after exposure to GYNECARE INTERCEED Adhesion Barrier. No teratogenic studies have
been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE
INTERCEED Adhesion Barrier. The safety and effectiveness of using GYNECARE INTERCEED Adhesion Barrier in combination with other
adhesion prevention treatments have not been clinically established.
GYNECARE INTERCEED Adhesion Barrier is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization,
GYNECARE INTERCEED Adhesion Barrier must not be resterilized.
Foreign body reactions may occur in some patients.
Interactions may occur between GYNECARE INTERCEED Adhesion Barrier and some drugs used at the surgical site.
Pathologists examining sites of GYNECARE INTERCEED Adhesion Barrier placement should be made aware of its usage and of the normal
cellular response to GYNECARE INTERCEED Adhesion Barrier ‘to facilitate proper evaluation of specimens'.
ADVERSE REACTIONS
The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may
occur in the presence of GYNECARE INTERCEED Adhesion Barrier.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
087421-180205
Rx Only
Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless
steel, nickel, or ferrous materials.
Warnings
The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T),
depending on the LINX model implanted. Scanning under different condition removed utilizing a laparoscopic technique that does not
compromise the option for traditional anti-reflux procedures. It is recommended that patients receiving the LINX device register their implant
with the MedicAlert Foundation (www.medicalert.org) or equivalent organization.
Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation.
Laparoscopic placement of the LINX device is major surgery and death can occur.
General Precautions
The LINX device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse
reactions may include explantation and/or replacement.
The use of the LINX device in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than
3 cm. The LINX device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm.
The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification)
esophagitis.
The safety and effectiveness of the LINX device has not been evaluated in patients with electrical implants such as pacemakers and
defibrillators, or other metallic, abdominal implants.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
• Scleroderma
• Suspected or confirmed esophageal or gastric cancer
• Prior esophageal or gastric surgery or endoscopic intervention
• Distal esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High
Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm
or Hypertensive LES
• Symptoms of dysphagia more than once per week within the last 3 months
• Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)
• Esophageal or gastric varices
• Lactating, pregnant or plan to become pregnant
• Morbid obesity (BMI >35)
• Age < 21
INDICATIONS
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary,
venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL®
ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL® NU-KNIT®, and SURGICEL® SNoW™ Absorbable Hemostats can be cut to size for use in
endoscopic procedures.
PRECAUTIONS
Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any
excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction, such as encapsulation of
the product, which may mimic artifacts on radiographic images, resulting in diagnostic errors and possible reoperation.
In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent
plugging of the urethra, ureter, or a catheter by dislodged portions of the product.
Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by
application of silver nitrate or any other escharotic chemicals.
If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the
skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has
stopped.
Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples:
controlling hemorrhage after tonsillectomy and controlling epistaxis.)
Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse
Reactions section of the complete product package insert).
ADVERSE EVENTS
“Encapsulation” of fluid and foreign body reactions have been reported.
There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.
Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in
bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was
placed in the anterior cranial fossa.
Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.
For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012. For complete product
information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product
package inserts.
063768-200213
INDICATIONS
SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and
small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® Powder can also be
applied in laparoscopic or other endoscopic procedures when used with the SURGICEL™ Endoscopic Applicator.
The SURGICEL™ Endoscopic Applicator is intended for use in delivering SURGICEL® Powder absorbable hemostat to bleeding surgical sites
through a 5 mm or larger trocar.
CONTRAINDICATIONS
• Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins.
• SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins.
• The SURGICEL® Powder and the SURGICEL™ Endoscopic Applicator devices were not designed for intraluminal procedures.
• When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal
cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted
pressure.
• SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with
callus formation and a theoretical chance of cyst formation.
WARNINGS
• SURGICEL® Powder is not intended for use on dry (non-bleeding) surfaces or for prevention of bleeding.
• Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided.
• SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances.
• SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may
result in powder scattering and device migration that may increase the risk of adhesion formation. In preclinical in vivo animal studies it was
demonstrated that SURGICEL® Powder does not increase the incidence of remote adhesions in laparoscopic procedures.
• Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for
systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.
• To prevent clogging with the SURGICEL™ Endoscopic Applicator Tip, do not touch the tip to wet surface. Be careful to avoid damaging tissue
with the rigid tip.
• Do not attempt to trim the applicator tip. Replace the tip if it becomes clogged.
PRECAUTIONS
• SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the
transfusion filters of blood-scavenging systems.
• Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove
any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.
• Use minimal amount of SURGICEL® Powder required to achieve hemostasis, and remove excess powder in the area of drains to prevent
clogging. In urological procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging
of the urethra, ureter, or a catheter by dislodged portions of the product.
• Since absorption of SURGICEL® Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of
silver nitrate or any other escharotic chemicals.
• If SURGICEL® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline
solution after bleeding has stopped.
• Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling
hemorrhage after tonsillectomy and controlling epistaxis).
ADVERSE EVENTS
• Paralysis and nerve damage have been reported when other SURGICEL® products were used around, in, or in proximity to foramina in bone,
areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
• Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL® products were placed in
the anterior cranial fossa (see WARNINGS and PRECAUTIONS).
• Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.
• Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and
sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose
ulcerations, dermabrasions, and donor sites) have also been reported.
• For more information and technical questions, call 1-800-795-0012. For complete information including indications, contraindications,
warnings, precautions, adverse reactions, and directions for use, consult the product package insert.
071582-190227
DESCRIPTION
SURGIFOAM® is a sterile, water-insoluble, malleable, porcine gelatin absorbable sponge or powder intended for hemostatic use by applying to a
bleeding surface.
ACTIONS
When used in appropriate amounts, SURGIFOAM® is absorbed completely within 4 to 6 weeks. When applied to bleeding mucosal regions, it
liquefies within 2 to 5 days.
INTENDED USE/INDICATION
SURGIFOAM®, used dry or saturated with sterile sodium chloride solution, is indicated for surgical procedures (except ophthalmic) for
hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or
impractical. Although not necessary, SURGIFOAM® can be used with thrombin to achieve hemostasis
CONTRAINDICATIONS
•Do not use SURGIFOAM® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to
mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
•Do not use SURGIFOAM® in intravascular compartments because of the risk of embolization. Do not use SURGIFOAM® in patients with known
allergies to porcine collagen
WARNINGS
• SURGIFOAM® should not be used in the presence of infection and should be used with caution in contaminated areas of the body
• SURGIFOAM® should not be used in instances of pumping arterial hemorrhage
• SURGIFOAM® will not act as a tampon or plug in a bleeding site.
• SURGIFOAM® should be removed if possible once hemostasis has been achieved because of the possibility of dislodgment of the device or
compression of other nearby anatomic structures.
• SURGIFOAM® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine,
the spinal cord, and/or the optic nerve and chiasm.
• The safety and effectiveness of SURGIFOAM® for use in ophthalmic procedures have not been established.
• SURGIFOAM® should not be used for controlling post-partum bleeding or menorrhagia.
• The safety and effectiveness of SURGIFOAM® have not been established in children and pregnant women.
PRECAUTIONS
• Safe and effective use of this product has been reported in a published neurologic retrospective study involving 1700 cases in Europe. Safe
and effective use has not been proven through randomized, controlled clinical studies in the United States.
• SURGIFOAM® is supplied as a sterile product and cannot be resterilized. When placed into cavities or closed tissue spaces, care should be
exercised to avoid overpacking. SURGIFOAM® Sponge may swell to its original size on absorbing fluids, creating the potential for nerve
damage.
• SURGIFOAM® should not be used for packing a cavity unless excess product not needed to maintain hemostasis is removed.
• Once hemostasis is achieved, any excess SURGIFOAM® should be carefully removed.
• SURGIFOAM® should not be used in conjunction with autologous blood salvage circuits. • SURGIFOAM® should not be used in conjunction
with methyl methacrylate adhesives. The safety and effectiveness for use in urological procedures have not been established through a
randomized clinical study.
• In urological procedures, SURGIFOAM® should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
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DESCRIPTION
SURGIFLO® Hemostatic Matrix Kit is intended for hemostatic use by applying to a bleeding surface.
ACTIONS
When used in appropriate amounts SURGIFLO® Hemostatic Matrix is absorbed completely within 4 to 6 weeks.
INTENDED USE/INDICATIONS
SURGIFLO® Hemostatic Matrix , mixed with with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic)
as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
CONTRAINDICATIONS
Do not use SURGIFLO® Hemostatic Matrix in intravascular compartments because of the risk of embolization.
Do not use SURGIFLO® Hemostatic Matrix in patients with known allergies to porcine gelatin..
Do not use SURGIFLO® Hemostatic Matrix in closure of skin incisions because it may interfere with the healing of skin edges. This interference
is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
WARNINGS
SURGIFLO® Hemostatic Matrix should not be used in the presence of infection and should be used with caution in contaminated areas of the
body.
SURGIFLO® Hemostatic Matrix should not be used in instances of pumping arterial hemorrhage. SURGIFLO® Hemostatic Matrix will not act as a
tampon or plug in a bleeding site.
SURGIFLO® Hemostatic Matrix should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas
of bony confine, the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.
Excess SURGIFLO® Hemostatic Matrix should be removed once hemostasis has been achieved.
The safety and effectiveness of SURGIFLO® Hemostatic Matrix for use in ophthalmic procedures has not been established.
SURGIFLO® Hemostatic Matrix should not be used for controlling post-partum intrauterine bleeding or menorrhagia.
The safety and effectiveness of SURGIFLO® Hemostatic Matrix has not been established in children and pregnant women.
The blue flexible applicatorTip should not be trimmed to avoid exposing internal guidewire.
The white straight applicatorTip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharpTip.
PRECAUTIONS
Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in
Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.
SURGIFLO® Hemostatic Matrix is supplied as a sterile product and cannot be resterilized.
SURGIFLO® Hemostatic Matrix should not be used for packing unless excess product that is not needed to maintain hemostasis is removed.
SURGIFLO® Hemostatic Matrix may swell up to 20% upon contact with additional fluid.
SURGIFLO® Hemostatic Matrix should not be used in conjunction with autologous blood salvage circuits.
SURGIFLO® Hemostatic Matrix should not be used in conjunction with methylmethacrylate adhesives.
In urological procedures, SURGIFLO® Hemostatic Matrix should not be left in the renal pelvis or ureters to eliminate the potential foci for
calculus formation.
DESCRIPTION
SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.
ACTIONS
When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.
INTENDED USE/INDICATIONS
SURGIFLO®, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when
control of bleeding by ligature or other conventional methods is ineffective or impractical.
CONTRAINDICATIONS
• Do not use SURGIFLO® in intravascular compartments because of the risk of embolization.
• Do not use SURGIFLO® in patients with known allergies to porcine gelatin.
• Do not use SURGIFLO® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to
mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
WARNINGS
• SURGIFLO® should not be used in the presence of infection and should be used with caution in contaminated areas of the body• SURGIFLO®
should not be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act as a tampon or plug in a bleeding site.
• SURGIFLO® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine,
the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.
• Excess SURGIFLO® should be removed once hemostasis has been achieved.
• The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures has not been established.
• SURGIFLO® should not be used for controlling post-partum intrauterine bleeding or menorrhagia.
• The safety and effectiveness of SURGIFLO® has not been established in children and pregnant women.
• The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.
• The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.
PRECAUTIONS
• Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in
Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.
• SURGIFLO® is supplied as a sterile product and cannot be resterilized. • SURGIFLO® should not be used for packing unless excess product that
is not needed to maintain hemostasis is removed. SURGIFLO® may swell up to 20% upon contact with additional fluid.
• SURGIFLO® should not be used in conjunction with autologous blood salvage circuits.
• SURGIFLO® should not be used in conjunction with methylmethacrylate adhesives. • In urological procedures, SURGIFLO® should not be left
in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
ADVERSE EVENTS
A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin
sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
• Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial
growth.
• Giant cell granulomas have been observed at implant sites when used in the brain.
• Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.
• Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including
cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and
impotence.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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Essential Product Information
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
INDICATION
VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by
standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
CONTRAINDICATIONS
Do not inject directly into the circulatory system.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.
Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
ADVERSE REACTIONS
The most common adverse reactions (reported in >1% of clinical trial subjects) were nausea and procedural pain.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package
insert.
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