V2 ICE Probe SL

Basic Information

• Brand Name: V2 ICE Probe SL
• Primary DI: 00868390000204
• Version / Model: VP0601
• Catalog Number: VP0601
• Company Name: SANARUS TECHNOLOGIES, INC.
• Labeler DUNS: 831350785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: adb3e029-bc26-45c7-b58b-a01006cb9e1f

Device Description

The V2 ICE Probe SL (2.4 mm) is a single use, disposable probe designed for use with the Visica 2 Treatment System. The primary components of the V2 ICE Probe consists of a surgical stainless steel probe with an electrical warming component and an integrated T-Type thermocouple for internal temperature feedback. The V2 ICE Probe temperatures are internally and continuously monitored by the Visica 2 Console.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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	00868390000204	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073533	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 60 – 85 Degrees Fahrenheit