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Device Explorer · FDA GUDID · GMDN 45140

Cryosurgical set

A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted

US‑registered devices67in commercial distribution
Companies5labelers on GUDID
Single‑use93%of device records
Sterile93%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Boston Scientific Corporation3451%
Varian Medical Systems, Inc.2639%
Xiamen Taft Medical Co.,Ltd.46%
Sanarus Technologies, Inc.23%
Uc-Care Ltd11%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation3451%
Varian Medical Systems, Inc.2639%
Xiamen Taft Medical Co.,Ltd.46%
Sanarus Technologies, Inc.23%
Uc-Care Ltd11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IceSphere™ 1.5 CX Cryoablation NeedleIceFORCE™ 2.1 CX L 90° Cryoablation NeedleIcePearl™ 2.1 CX L 90° Cryoablation NeedleThree IcePearl® 2.1 CX Prostate Cryoablation KitThree IceFORCE ® 2.1 CX Prostate Cryoablation KiIcePearl® 2.1 CX Prostate Cryoablation Kit / VisIceFORCE® 2.1 CX Prostate Cryoablation Kit / VisIceFORCE® 2.1 CX Cryoablation NeedleIcePearl® 2.1 CX Cryoablation NeedleIceFORCE® 2.1 CX 90° Cryoablation NeedleIcePearl® 2.1 CX 90° Cryoablation NeedleIceRod® i-Thaw® Prostate Cryoablation Kit / VisuIceSphere® 1.5 90° Cryoablation NeedleIceSphere® 1.5 Cryoablation NeedleIceRod® 1.5 CX 90° Cryoablation NeedleIceRod® 1.5 PLUS Cryoablation Needle

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, Accessories63
GEHUNIT, CRYOSURGICAL, ACCESSORIES12
KNNComponents, Wheelchair4
NEYSystem, Ablation, Microwave And Accessories2

GMDN & GCC registration

  • GMDN code 45140 · non‑implantable
  • Single‑use 93% · sterile 93% · Rx‑only 81% · OTC 0%
  • 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) · 17Shaft Length (Millimeter) · 3Needle Gauge (Gauge) · 3Length (Millimeter) · 3

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

How many cryosurgical set products are registered in the US?

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cryosurgical set", from 5 companies. The largest labeler is Boston Scientific Corporation with 51% of records.

Which FDA product codes apply?

GEH (Unit, Cryosurgical, Accessories), GEH (UNIT, CRYOSURGICAL, ACCESSORIES), KNN (Components, Wheelchair), NEY (System, Ablation, Microwave And Accessories)

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.

How do I get quotes?

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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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