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Amerigel 1

by Amerx Healthcare Corp

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00361470101414 UDI-DI Date28 Sep 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Amerigel
Generic Name
Wound hydrogel dressing, non-antimicrobial
Model / Ref / Catalog
1, A2001
Primary DI / UDI-DI
00361470101414
FDA Product Code
FRO
GMDN Term
Wound hydrogel dressing, non-antimicrobial
Device Class
U
GUDID distribution status
Not in Commercial Distribution

Other devices from Amerx Healthcare Corp

Properties

  • Over-the-Counter
  • Combination Product
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No