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Gynex CSU3900-5

by Gynex Corporation

Gynex CSU3900-5 is a Class I device made by Gynex Corporation, listed in FDA GUDID since 19 Dec 2023 (UDI-DI GYNXCSU390050), 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 NumberGYNXCSU390050 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  • Withdrawn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
Endometrial biopsy curette
Model / reference
CSU3900-5
Primary DI / UDI-DI
GYNXCSU390050
FDA product code
HCY
GMDN term
Endometrial biopsy curette
Device class
Class I
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endometrial biopsy curette

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)