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Kegel HD-05

by Star Port 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860015727336 UDI-DI Date27 Apr 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  • Withdrawn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
Kegel
Generic Name
Wound hydrogel dressing, non-antimicrobial
Model / Reference
HD-05
Primary DI / UDI-DI
00860015727336
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
Sterilization Method
Ethylene Oxide

Other devices from Star Port Inc

Properties

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

Other properties (8)

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