EZ U.S. FOOD & DRUG Le eee ADMINISTRATION Sess tw Ss Certificate No. 7649-42022 CERTIFICATE TO FOREIGN GOVERNMENT 'n order to allow the importation of United States products into foreign countries , the U.S. Food and Drug ‘Administration (FDA) certifies the following information concerning the product(s) to be exported listed below. Name of Product(s) Name of Manufacturer/Distributor, Address See Attached List Name of Manufacturer Legal Manufacturer (Three Pages) INTEGRA LIFESCIENCES CORPORATION 4900 CHARLEMAR DR,, BUILDING A, CINCINNATI, OH USA 45227 ‘The product(s) described above (and the manufacturing/distribution site(s) which producesidistribules it) is subject {o the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. certified that the above product(s) may be marketed in, and legally exported from, the United States of ‘America at this timo, The manufacturing plan\(s) in which the product(s) Is produced is subject fo periodic Inspections. The last such inspection showed that the plants), at that time, appeared to be in substantial ‘compliance with current good manufacturing practice requiraments for the product(s) isted above. Sincerely, CDR Cesar A. Perez, PRD, Director DRP2: Division of Establishment Support Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food and Drug Administration, DHHS This certificate is valid from April 18, 2022 to April 17, 2024.ivy U.S. FOOD & DRUG Ug Fd Gn ran ADMINISTRATION Siipee toa Certificate No. 7649-4-2022 Certificate to Foreign Government - Name of Product(s) Attachment Page 1 of 3 Mame of Manufecturar 7 rer INTEGRA LIFESCIENCES CORPORATION 4900 CHARLEMAR DR, BUILDING A CINCINNATI, oF Usa4sea7 Name of Product(s) Paget Noda BElecic Dernatome 1DP-2001: Medet 5 Hanapice win Cord 10P-0002: Power Suny (120). Me 'DP-0006: Power Supply (230), Medet B 3599-240: Garyng Case, Paste 8598-250; Model 8 (120¥)- Dematorne Compa Kt :3539-250250: Mode B (230) -Darmatomo Complte Kot 9599252: Demmaome Blados Store, Single Use, Box of 10 9590.255-0: Guard Pato, Dematome Head Assembly .2698.2561: 1" (254 cm) Wath Bade Clip 598.255.2208 en) Weth Blade Cp 500.266 3: (7.62 am) Will Blade Cp 3550-2564: (10.48 cm) Wit Blade Cp 2500-256: With Cip Scrow (set of2) 596257: Darmatome Serewivr 3598258: Pin Position Guide 3590-700: negra Padgett Unversal Damatome Sterizing Tray Padget Modo C ir ermetome ‘AP-2001: Model C Ar Dermetome Handiece |AP-0305: Gran Ar Gasket 3599-240: Canying Case, Plato 599252; Dermat Blades toro, Single Use, Hox of 10 £2599286-0; Guar Pate, Dematome Head Assembly 9998-200: 1 (2.54 om) Wath Bue Cip £3598.268.2:2" (6.08 em) Wath Bade Chip 509206-8 "(7.62 cm) Wath Blade Cip 9509.286-4: 4" (10-16 cm) Wen Blade Cip 53559.257: Damatome Seremrver 3608-258: Pin Peston Gude 859940": 12 (3.58 m Maniacs Ar Hose 3509-000: Mo G- Air Dermatoma Complete Kt 2596-798: nigra Padyet Universal Danntome Stortzing Tay Dermateme Mode. Padget Elec Dermatome 'DP-c003: Model Pt Handsiace with Cont 1-000: Pomer Supply (120), Mel PI P0006: Power Sup (230) 598-256: Wily Cp Scrow (eto 2 3539257. Demaiome Scrver 3598-250, Pin Poston Guise 3500600: Mode! Pt (120V) -Dermatome Conglota Kit 3539€00-200: Moe! Pl (230V)-_Dermatome Complete Kit ‘3596-602 Dermatars lados, Ste, Sngle Use, Bax of 10 2680-6100: Guard iets. Dermstome Head Amy 3598.610-1: 1 (254 om) Width Blade Cp 3890.6102 7" (6.08 om) With Blade Cp 3530.610.: 3 (7.52 em) Wath lace Cp 388051044" (10.16 cr) With Blade Cin 3598610.5 5° (12.70 em) Widh Blade Cp 3598.810.8. 6 (15.28 on) With Bladen.ipiN U.S. FOOD & DRUG Ua tet gcuin ADMINISTRATION Ser Spine MD 02 Cortificate No. 7649-4.2022 Certificate to Foreign Government - Name of Product(s) Attachment Page 2 of 3 9598-612: Canying Case, Piste 3599.60: Power Supply Wall Cord, (120V), US 2590-799: Intagra Padget Univeral Darmatome String Tray Deumatome Noda Simin Domatome ‘DP.0007: Power Supply Model S and $5 [DP-0000: MANIPOLO DERMOTOMO S 1DP-0010: Medel $5 Handieco 598.235: Poor Supply Wal Cord 3890-200: Power Supty Wall Cord 9598-227: Power Supely Wall Cort 3999240: Camyng Case, Plastic 3599252: Dorrstoe Blas, Stare, Single Uso, Box of 10 3530-258 wah Cp Soren (at of 2) 3538257: Dermatome Serewerver 3599.206-0: Guard Pate, Dematome Head Assembly £3696-266-1: 1 (252 on) Wath Blade Cip 590.2662: 7 (508 cm) Wen lade Cip 3598-2663: 5 (762m) Wh Blade Cp 3590-2864: "(10.16 on) Wath Bide Cp 3598620: 120V Power Suoply Wall Cor) 3590700: Made 8 (110-230V) - Snine Demmatore Compete Unit 3598-701: Damatome Hox Nut(1 each) 13580 702: Dermatone Wrench 3596-71513: 19 (2.98 m) Handpiece Cable 13500-71525: 25 (7.62 m) Handpions Cable 3530-799: negra Padgett Universal Deratome Sterling Tray Dermatome Model $5 Electc Smine Dermatome 'DP-0007: Power Supp, 1BP-0D10: Modo! S6 Handpiece '3590:235: Power Supply Wall Cont .3598:236, Power Supply Wall Cord 3630-257: Power Supply Wal Cond '3598.240:Conying Caco, Plasto 2500-256: with Cp Serow (eat of 2) 390.280: Pi Poston Guido 3539.257- Damas Sermnshiver 3508-420: 120V Power Supply Walt Cos 359870": Dannatome Hox (1 each) 3599-702: Dest Wrench 3598-71643: 19 8 m) Handpiece Cable .9008-715:25: 26 (62m) Handpiece Cable 590-799: negra Padgt Unversl Dormtome Strong Trey 3599-600: Mod Sé6 (110-230¥)Simine Deratome Complete Unit 3538-9100: Guard Plato, Darteme Head Assertly 8598 910-1: 1 254 cm) Wid lade Cp 85909102 2" (508 cm) Wish ade Cp 3599.810-8: 5 (7.62 on) Width Blade Cip 8508: 4° (10.16 cm) Wan Blade Cap 1509610-5.5° (127 om) Wem Blade Cp 13898-8100: 6°(15.26m) vem Bae Cp Padgett Manval Darratrne 9590-007: Kt, Manual Dermatore, Masur 4°) 3599-1006TA: Ki, Manual Deratome, Large (5), '3520-100B7A: 1, Mana Darmatome, Gre (2) 3590-01: Four Inch Manual Dermetome (Orum & Stand) 4x8 inch size 35901015. Five Inch Manual Dematome (Dru & Stand) 58 ch ize 3530-102: Tres ict Moral Dermatorne (Oram & Stand) Se ich sine< Se i=) U.S. FOOD & DRUG € ADMINISTRATION —: Certificate No. 7649-4.2022 Certificate to Foreign Government - Name of Product(s) Attachment Page 3 of 3 '2590:106; Blade, Dermatoms (For Manual Modal, Regu Sco} 2690-108: Bade, Dormatome (For Manus Models, Regular Sze) 3558-115: Caryng Case 3500-117. Taciness Gauge 3506-118: Szrows oe 36991188 and 3530118 3590-1520: Padgett Dematome Tape (10x) ‘Sun Graft Mosher Products PTO: Mesh Skin Gat Bxpandor 172 Teflon Roi fr Skin eat Expander PITS: Roller and Hand (completa, er P70) z END OF PRODUCT LIST 13 Food Gru Aniston ‘SivrSpng MO 209