ELEKTA INSTRUMENT AB Data Sheet (DAS)

Issuer: Date: Page

Petter Grelsson 2017-03-24 1(2)
Name: Description (UPPER CASE, max 30 characters): Revision:
1526880 LABEL FIXATION SCREW TITANIUM 02

Specification

Generel Specifications Value

Size (width x height) Approx. 60 x 30mm
Material The background shall be white and the text shall be black. The backside shall have adhesive
suitable for corresponding contact surface. The label shall remain attached and maintain
readability during foreseeable transport and storage conditions. Label must be REACH compliant.

Field Variable (Y/N) Value or instructions Font or Size (approx.)

Product name Y Product name: according to cross reference Calibri, pt. 10
list below.

‘Catalogue number’ symbol Y Symbol: ISO 15223-ISO 7000-2493 Height: 5mm

Product number: XXXXXXXX Calibri, pt. 8
according to cross reference list below.
‘Batch code’ symbol Y Symbol: ISO 15223-ISO 7000-2492 Height: 5mm
Lot Number: YYZZZZZZZZ Calibri, pt. 8
‘Caution’ symbol N Symbol: ISO 15223-ISO 7000-0434A Height: 5mm
‘Rx Only’ symbol N CAUTION: Federal law restricts this Height: 5mm
device to sale by or on the order of a
licensed healthcare practitioner.
CE mark N A minimun height of 5 mm is required to Height: 5mm
ensure that it is legible. Add also 0413.
Data matrix Y Type: DataMatrix according to GS1 X-dimension:

ECO-0008555, STATUS: RELEASED, DATE: 18-04-2017, TIME: 14:41 GMT

specification for GS1 data matrix ECC200 Min. = 0.255 mm
Target = 0.380 mm
Max. = 0.495 mm
Height is determined by X-
dimension and data that is
encoded.
Quiet zone: 1x X-dimension on
all four sides.
Minimum quality: 1.5/08/660
GS1 DataMatrix content Y AI 01 = GTIN (AAAAAAAAAAAAAA) Calibri, pt. 5
according to cross reference list below. Data matrix content and human
Y AI 10 = Lot/Batch Number (YYZZZZZZZZ) readable interpretation(HRI)
must be set up with the
Y AI 240 = Part Number (XXXXXXXX) application identifiers(AI) in the
according to cross reference list below. specified order.
‘Manufacturer’ symbol N Symbol: ISO 15223-ISO 7000-3082 Height: 5mm
Manufacturer name and adress N Elekta Instrument AB Calibri, pt. 5
Kungstensgatan 18
Box 7593
SE-103 93 Stockholm, Sweden
Company logo N Elekta logo 20 x 6 mm
Label specification no. - revision N 1526880-02 Calibri, pt. 4

BL0012 version 9 C3934/C4143/C4273/C4381/C5248/C5354/C5360

If you use this template from EPDM: Make sure this template is equivalent with the applicable version released in BANS EIAB BMS.
When updating this template: Be aware of that this template is integrated in EPDM System, which then needs to be updated with the valid version.
ELEKTA INSTRUMENT AB Data Sheet (DAS)
Issuer: Date: Page
Petter Grelsson 2017-03-24 2(2)
Name: Description (UPPER CASE, max 30 characters): Revision:
1526880 LABEL FIXATION SCREW TITANIUM 02

Specification

Product number Product name GTIN

404888 TITANIUM FIXATION SCREW, 20 MM 07340048301893
404889 TITANIUM FIXATION SCREW, 22.5 MM 07340048301909
404890 TITANIUM FIXATION SCREW, 25 MM 07340048301916
707478 TITANIUM FIXATION SCREW, 30 MM 07340048301930
707479 TITANIUM FIXATION SCREW, 35 MM 07340048301954
707480 TITANIUM FIXATION SCREW, 40 MM 07340048301978
707481 TITANIUM FIXATION SCREW, 45 MM 07340048301992
707482 TITANIUM FIXATION SCREW, 50 MM 07340048302005
707483 TITANIUM FIXATION SCREW, 55 MM 07340048302012
707484 TITANIUM FIXATION SCREW, 60 MM 07340048302029
709667 TITANIUM FIXATION SCREW, 27.5 MM 07340048301923
709668 TITANIUM FIXATION SCREW, 32.5 MM 07340048301947
709669 TITANIUM FIXATION SCREW, 37.5 MM 07340048301961
709670 TITANIUM FIXATION SCREW, 42.5 MM 07340048301985
709671 TITANIUM FIXATION SCREW, 65 MM 07340048302036
709672 TITANIUM FIXATION SCREW, 70 MM 07340048302043
709673 TITANIUM FIXATION SCREW, 75 MM 07340048302050
709674 TITANIUM FIXATION SCREW, 80 MM 07340048302067
709675 TITANIUM FIXATION SCREW, 90 MM 07340048302074
709676 TITANIUM FIXATION SCREW, 110 MM 07340048302081
Export Control requirements for computing & networking items:
Given the scope, risks and complications created by US reexport controls, it is generally desirable to avoid US origin, or if possible keep
the US content below 10% and therefore outside of US jurisdiction. Elekta will require suppliers to provide information on export
control information; Export Control Classification Number (ECCN), country of manufacture and US content on in order to summarize
export control restrictions on top sales levels.
This has large impact on spares, e.g. a motor from US can be ok to export as a part of a system but not as a spare part.

ECO-0008555, STATUS: RELEASED, DATE: 18-04-2017, TIME: 14:41 GMT

Manufacturer/Supplier specification
Selected manufacturer and manufacturer´s part number:

Possible suppliers and supplier’s part number:

Remarks

Note:
To Elekta’s supplier: Supplier is not allowed to make changes to product without informing Elekta.

BL0012 version 9 C3934/C4143/C4273/C4381/C5248/C5354/C5360

If you use this template from EPDM: Make sure this template is equivalent with the applicable version released in BANS EIAB BMS.
When updating this template: Be aware of that this template is integrated in EPDM System, which then needs to be updated with the valid version.