DEVICE: Biatain Silicone Sacral (05708932674867)

Device Identifier (DI) Information

Biatain Silicone Sacral
39001
In Commercial Distribution
39001
Coloplast A/S
05708932674867
GS1

1
305524696 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44970 Exudate-absorbent dressing, non-gel, non-antimicrobial
A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, wound, occlusive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight. Do not use if package is damaged and consult IFU.
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Clinically Relevant Size

[?]
Size Type Text
Width: 7.5 Inch
Length: 6 Inch
Device Size Text, specify: Pad Width - in 5.5
Device Size Text, specify: Pad Length - cm 11
Width: 19 Centimeter
Device Size Text, specify: Pad Length - in 4.3
Device Size Text, specify: Dressing Shape Sacral
Device Size Text, specify: Pad Width - cm 14
Length: 15 Centimeter
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Device Record Status

8adacd3e-504d-4a51-ace6-e9a94a2dbe87
December 08, 2022
1
November 30, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932674874 5 05708932674867 In Commercial Distribution Retail Box
05708932674881 16 05708932674874 In Commercial Distribution Shipper Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
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