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Novera Balance NVHYGE025G

by Harps USA, Inc.

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 Number00841277111248 UDI-DIDate4 Sep 2026ListedStatusListed 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  • Withdrawn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
Novera Balance
Generic Name
Wound hydrogel dressing, non-antimicrobial
Model / Ref / Catalog
NVHYGE025G
Description
Hydrogel, Tube 1pk/box, 50box/inner case, 8 inner case/ctn
Primary DI / UDI-DI
00841277111248
FDA Product Code
NAE
GMDN Term
Wound hydrogel dressing, non-antimicrobial
Device Class
Class I
Regulation Number
878.4022
GUDID distribution status
Not in Commercial Distribution

Other devices from Harps USA, Inc.

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Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Premarket Exempt

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No