SILVERCEL Non-Adherent Silver Alginate
by Advanced Medical Solutions Limited 4 variants
SILVERCEL Non-Adherent Silver Alginate (900112) is a device classified as Unclassified made by Advanced Medical Solutions Limited, cleared under FDA 510(k) K081363 on 24 Sep 2008 and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 15051978002499), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15051978002499 | Date7 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081363 | Date24 Sep 2008 | StatusActive |
Official records
- AccessGUDID record 15051978002499
- FDA 510(k) database K081363
Across registries
- FDA 510(k) K081363 decided 24 Sep 2008 Active
- FDA GUDID UDI-DI 15051978002499 listed 7 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K081363
- Listed FDA GUDID 15051978002499
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Silvercel
- Generic name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
- Model / Ref / Catalog
- Non-Adherent Silver Alginate, 900112
- Primary DI / UDI-DI
- 15051978002499
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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