DEVICE: Biatain Silicone .pdf) (05701780261579)
Device Identifier (DI) Information
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.
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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 |
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Special Storage Condition, Specify: Do not use if package is damaged and consult IFU. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 30 Centimeter |
Device Size Text, specify: Pad Length - in 10 |
Device Size Text, specify: Pad Width - cm 5.5 |
Width: 10 Centimeter |
Length: 11.8 Inch |
Device Size Text, specify: Dressing Shape Rectangular |
Device Size Text, specify: Pad Width - in 2.2 |
Device Size Text, specify: Pad Length - cm 25.5 |
Width: 4 Inch |
Device Record Status
e2ed45a4-aa14-413e-848c-311bd12d9c2d
December 08, 2022
1
November 30, 2022
December 08, 2022
1
November 30, 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 |
---|---|---|---|---|---|
05708932579339 | 20 | 05708932579322 | In Commercial Distribution | Shipper Box | |
05708932579322 | 5 | 05701780261579 | 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