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Renasys 66803107

by Smith & Nephew Medical, Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05000223499198 UDI-DI Date23 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Renasys
Generic Name
Wound dressing kit, medicated
Model / Ref / Catalog
66803107
Primary DI / UDI-DI
05000223499198
FDA Product Code
OMP
GMDN Term
Wound dressing kit, medicated
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Smith & Nephew Medical, Ltd.

See all devices from Smith & Nephew Medical, Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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