DEVICE: Biatain Silicone .pdf) (05708932576055)

Device Identifier (DI) Information

Biatain Silicone .pdf)
33435
In Commercial Distribution
33435
Coloplast A/S
05708932576055
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: Do not use if package is damaged and consult IFU.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Pad Width - cm 6.5
Length: 10 Centimeter
Length: 4 Inch
Width: 4 Inch
Device Size Text, specify: Pad Length - in 2.6
Device Size Text, specify: Pad Width - in 2.6
Width: 10 Centimeter
Device Size Text, specify: Pad Length - cm 6.5
Device Size Text, specify: Dressing Shape Square
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Device Record Status

e467b87e-f40a-42ae-94bb-7f49d8493e7e
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
05708932576031 10 05708932576055 In Commercial Distribution Retail Box
05708932576048 24 05708932576031 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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