DEVICE: Biatain Super, Non-Adhesive (05708932536806)
Device Identifier (DI) Information
Biatain Super, Non-Adhesive
46320
In Commercial Distribution
46320
Coloplast A/S
46320
In Commercial Distribution
46320
Coloplast A/S
No description.
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAD | Dressing, wound, occlusive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Pad Length - cm 7 |
Length: 5 Inch |
Length: 12.5 Centimeter |
Device Size Text, specify: Pad Length - in 3 |
Width: 12.5 Centimeter |
Device Size Text, specify: Pad Width - in 3 |
Device Size Text, specify: Pad Width - cm 7 |
Device Size Text, specify: Dressing Shape Square |
Width: 5 Inch |
Device Record Status
c234c9a3-54e4-462e-bd2e-c72e0bd5fffc
December 13, 2022
1
December 05, 2022
December 13, 2022
1
December 05, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05708932536820 | 24 | 05708932536813 | In Commercial Distribution | Shipper Box | |
05708932536813 | 10 | 05708932536806 | In Commercial Distribution | Retail Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com