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ClariFix CFX-0001

by Arrinex, Inc.

ClariFix CFX-0001 is a general cryosurgical system (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Arrinex, Inc., listed in FDA GUDID since 4 Apr 2018 (UDI-DI 00868438000203), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868438000203 UDI-DI Date4 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
ClariFix
Generic name
General cryosurgical system, cryogen gas, mechanical
Model / reference
CFX-0001
Primary DI / UDI-DI
00868438000203
FDA product code
GEH
GMDN term
General cryosurgical system, cryogen gas, mechanical
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: General cryosurgical system, cryogen gas, mechanical

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from Arrinex, Inc.

See all devices from Arrinex, Inc. →

Properties

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