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3M™ Silvercel™ 900404

by 3M Deutschland GmbH

3M™ Silvercel™ 900404 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 25032749039422), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K081363

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number25032749039422 UDI-DI Date2 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081363 Date24 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081363 decided 24 Sep 2008 Active
  • FDA GUDID UDI-DI 25032749039422 listed 2 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081363
  2. Listed FDA GUDID 25032749039422

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
3M™ Silvercel™
Generic name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Model / Ref / Catalog
900404
Primary DI / UDI-DI
25032749039422
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).

Other devices from 3M Deutschland GmbH

See all devices from 3M Deutschland GmbH →

Properties

  • Supplied sterile
  • Single use
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)