DEVICE: Biatain Fiber Ag (05708932764636)

Device Identifier (DI) Information

Biatain Fiber Ag
33570
In Commercial Distribution
33570
Coloplast A/S
05708932764636
GS1

1
305524696 *Terms of Use
No description.
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FRO Dressing, wound, drug
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K231953 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 2 Inch
Length: 5 Centimeter
Width: 2 Inch
Width: 5 Centimeter
Device Size Text, specify: Dressing Shape Square
CLOSE

Device Record Status

19f4f35c-fe22-4075-bb3a-9431e90b576c
December 02, 2024
1
November 22, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932764582 10 05708932764636 In Commercial Distribution Retail Box
05708932764537 60 05708932764582 In Commercial Distribution Shipper Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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