Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit Visual-ICE® System

Basic Information

• Brand Name: Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit Visual-ICE® System
• Primary DI: 07290104831058
• Version / Model: FPRPR3607
• Catalog Number: FPRPR3607
• Company Name: GALIL MEDICAL LTD
• Labeler DUNS: 531854560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 6
• Public Version Date: 2022-02-04
• Public Version Status: Update
• Public Device Record Key: ced34ba2-aca9-4d32-a628-16933106fc2a

Device Description

Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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 portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290104831058	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Kit including: Cryoablation Needles 2.1 mm Shaft Diameter; Thermal Sensors Shaft Diameter 1.5 mm; Needle Shaft Length 175 mm; Urethral Warming Set

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool, Dry, Place