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Gentle Vac 17420

by Axcesor LLC

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 Number10861372000305 UDI-DI Date20 Mar 2017ListedStatusListed 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  • Withdrawn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
Gentle Vac
Generic Name
Foetal vacuum extraction system cup, reusable
Model / Reference
17420
Primary DI / UDI-DI
10861372000305
FDA Product Code
HDB
GMDN Term
Foetal vacuum extraction system cup, reusable
Device Class
Class II
Regulation Number
884.4340
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide

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