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Cohesive Wrap - 2"x 5 yds - UDI/10 R228-346

by Certified Safety Manufacturing, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10766588283460 UDI-DI Date4 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1060-2022 FDA Class II initiated 5 Apr 2022 on shared 510(k) K940249

    First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cohesive Wrap - 2"x 5 yds - UDI/10
Generic Name
General surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
R228-346
Primary DI / UDI-DI
10766588283460
510(k) Number
FDA Product Code
HTD
GMDN Term
General surgical procedure kit, non-medicated, single-use
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K940249)

Show all (12)

Other devices from Certified Safety Manufacturing, Inc.

See all devices from Certified Safety Manufacturing, Inc. →

Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No