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Device Explorer · FDA GUDID · GMDN 11067

General cryosurgical system, cryogen gas, mechanical

An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically i

US‑registered devices450in commercial distribution
Companies28labelers on GUDID
Single‑use15%of device records
Sterile12%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Coopersurgical, Inc.11024%
Brymill Corporation6414%
Atricure, Inc.5212%
H & O Equipments Sa5011%
Premier Dental Products Company307%
Medtronic, Inc.225%
Cryosurgery, Inc.184%
Nuance Medical, Llc133%

Top labelers

CompanyDevicesShare
Coopersurgical, Inc.11024%
Brymill Corporation6414%
Atricure, Inc.5212%
H & O Equipments Sa5011%
Premier Dental Products Company307%
Medtronic, Inc.225%
Cryosurgery, Inc.184%
Nuance Medical, Llc133%
Integra Lifesciences Production Corporation102%
Cryoconcepts, Lp92%
Us Endoscopy92%
Phakos82%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CryoIQ Dermatology tip D3CryoIQ Dermatology tip D2CryoIQ Dermatology tip D1CryoIQ PRO liquid D2CryoIQ DERM plus liquidCryoIQ 25g N2O cartridgeCryoPro miniCryoPro maxiERBEE-Cylinder Adapter 50008 CO2E-Cylinder Adapter 50007 N2OLL100™ Two-Trigger Multi-Tip Cryosurgical SystemWallach Accu-ShieldWALLACHFrigitronicsFrigitronics Probe

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GEHUnit, Cryosurgical, Accessories401
GEHUNIT, CRYOSURGICAL, ACCESSORIES43
OCLSurgical Device, For cutting, coagulation, and/or ablation o23
GXHDevice, Surgical, Cryogenic16
HRNUnit, Cryophthalmic, Ac-Powered8
MLYVapocoolant Device2

GMDN & GCC registration

  • GMDN code 11067 · non‑implantable
  • Single‑use 15% · sterile 12% · Rx‑only 66% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 39Length (Millimeter) · 38Total Volume (Milliliter) · 30Length (Centimeter) · 29Length (Inch) · 5

Use these as the dimensions to specify in a tender line.

How many general cryosurgical system, cryogen gas, mechanical products are registered in the US?

450 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General cryosurgical system, cryogen gas, mechanical", from 28 companies. The largest labeler is Coopersurgical, Inc. with 24% of records.

Which FDA product codes apply?

GEH (Unit, Cryosurgical, Accessories), GEH (UNIT, CRYOSURGICAL, ACCESSORIES), OCL (Surgical Device, For cutting, coagulation, and/or ablation o), GXH (Device, Surgical, Cryogenic)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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