DEVICE: Biatain Fiber Ag (05708932764599)

Device Identifier (DI) Information

Biatain Fiber Ag
33572
In Commercial Distribution
33572
Coloplast A/S
05708932764599
GS1

1
305524696 *Terms of Use
No description.
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
Yes
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?
47474 Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, 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
FRO Dressing, wound, drug
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K231953 000
No 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. Do not resterilize.
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Clinically Relevant Size

[?]
Size Type Text
Width: 4 Inch
Length: 12 Centimeter
Device Size Text, specify: Dressing Shape Rectangular
Width: 10 Centimeter
Length: 5 Inch
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Device Record Status

19e3daf1-dc8a-4946-a629-d5ad4f104f3b
December 02, 2024
1
November 22, 2024
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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
05708932764490 40 05708932764544 In Commercial Distribution Shipper Box
05708932764544 10 05708932764599 In Commercial Distribution Retail 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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