3M™ Silvercel™ 900112
3M™ Silvercel™ 900112 is a device classified as Unclassified made by 3M Deutschland GmbH, cleared under FDA 510(k) K081363 on 24 Sep 2008 and listed in FDA GUDID since 2 Jun 2023 (UDI-DI 25032749039446), 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 | Number25032749039446 | Date2 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081363 | Date24 Sep 2008 | StatusActive |
Official records
- AccessGUDID record 25032749039446
- FDA 510(k) database K081363
Across registries
- FDA 510(k) K081363 decided 24 Sep 2008 Active
- FDA GUDID UDI-DI 25032749039446 listed 2 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K081363
- Listed FDA GUDID 25032749039446
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 3M™ Silvercel™
- Generic name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
- Model / Ref / Catalog
- 900112
- Primary DI / UDI-DI
- 25032749039446
- 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).
- DRYODINE CADEXOMER-IODINE GEL by Collegium Pharmaceutical Incorporated
- Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) by Roosin Medical Devices Co., Ltd.
- DUODERM FLEXIBLE HYDROACTIVE DRESSINGS by Convatec, A Division of E.R. Squibb & Sons
- PROWICK by Arthrex, Inc.
- JELONET PARAFFIN GAUZE DRESSINGS by ACME UNITED CORP.
- DERMASSIST PETROLATUM GAUZE, USP by Wilshire Medical Products
- BIAFINE Topical Cream by Bausch Health Americas Incorporated
- AMSure®Sterile Water for Wound Flush 1 AS399-1 by AMSINO INTERNATIONAL, INC.
- PRONTOSAN WOUND GEL X by B. Braun Medical, Inc.
- WOUNDWASH SALINE SPRAY by NeilMed Pharmaceuticals Inc.