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cryoICE® cryoFORM™

by Atricure, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10840143912801 UDI-DI Date29 Sep 2026ListedStatusListed 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  • Withdrawn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

Generic name
General cryosurgical system, cryogen gas, mechanical
Model / Ref / Catalog
CRYOF, A001562
Primary DI / UDI-DI
10840143912801
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
Size
Length — 10 Centimeter

Other devices from Atricure, Inc.

See all devices from Atricure, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No