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Gynex 4675

by Gynex Corporation

Gynex 4675 is an uterine sound (FDA Class I; FDA product code HHM, Sound, Uterine) made by Gynex Corporation, listed in FDA GUDID since 19 Dec 2023 (UDI-DI GYNX46751), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberGYNX46751 UDI-DI Date19 Dec 2023ListedStatusListed 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  • Withdrawn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
Gynex
Generic name
Uterine sound, single-use
Model / reference
4675
Primary DI / UDI-DI
GYNX46751
FDA product code
HHM
GMDN term
Uterine sound, single-use
Device class
Class I
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uterine sound, single-use

Similar devices

Other devices filed under FDA product code HHM (Sound, Uterine).

Other devices from Gynex Corporation

See all devices from Gynex Corporation →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)