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HyFer HerNon Neo HC gel 5HP

by MOON-X USA, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809319802631 UDI-DI Date3 Aug 2026ListedStatusListed 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  • Withdrawn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
HyFer HerNon
Generic Name
Wound hydrogel dressing, non-antimicrobial
Model / Reference
Neo HC gel 5HP
Primary DI / UDI-DI
08809319802631
FDA Product Code
NAE
GMDN Term
Wound hydrogel dressing, non-antimicrobial
Device Class
Class I
Regulation Number
878.4022
GUDID distribution status
In Commercial Distribution

Properties

  • Sterile
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No