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Hybrid Dressing - Revo Unsterile HFD-D1030-UNS

by Genadyne Biotechnologies 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 Number00849405002819 UDI-DI Date16 Mar 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  • Withdrawn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
Hybrid Dressing - Revo Unsterile
Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Model / Reference
HFD-D1030-UNS
Primary DI / UDI-DI
00849405002819
FDA Product Code
OMP
GMDN Term
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution

Other devices from Genadyne Biotechnologies Inc.

See all devices from Genadyne Biotechnologies Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: 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