ActivHeal Silver Alginate
by Advanced Medical Solutions Limited 6 variants
ActivHeal Silver Alginate (9023274) is a device classified as Unclassified made by Advanced Medical Solutions Limited, cleared under FDA 510(k) K080503 on 12 Nov 2008 and listed in FDA GUDID since 3 May 2023 (UDI-DI 15032749023271), 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 | Number15032749023271 | Date3 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080503 | Date12 Nov 2008 | StatusActive |
Official records
- AccessGUDID record 15032749023271
- FDA 510(k) database K080503
Across registries
- FDA 510(k) K080503 decided 12 Nov 2008 Active
- FDA GUDID UDI-DI 15032749023271 listed 3 May 2023 Listed
Timeline
- Cleared FDA 510(k) K080503
- Listed FDA GUDID 15032749023271
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ActivHeal
- Generic name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
- Model / Ref / Catalog
- Silver Alginate, 9023274
- Primary DI / UDI-DI
- 15032749023271
- 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
Similar devices
Other devices filed under FDA product code FRO (Dressing, Wound, Drug).
- AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS by Aubrey, Inc.
- Skin and Wound Cleanser by WINNER MEDICAL CO., LTD.
- ENLUXTRA HUMIFIBER WOUND DRESSING by Basf Venture Capital America, Inc.
- KALTOCARB WOUND DRESSING by Calgon Vestal Div.
- LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM by Huizhou Foryou Medical Devices Co.,Ltd.
- KALTOSTAT WOUND PACKING by Calgon Vestal Div.
- CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL by Avery Dennison Belgie Bvba
- SORBACT by ABIGO Medical AB
- EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS by Euromed, Inc.
- Suprasorb A + Ag “R” by SPECIALITY FIBRES AND MATERIALS LIMITED