V2 ICE Probe SL VP0601

GUDID 00868390000204

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.

SANARUS TECHNOLOGIES, INC.

Cryosurgical set

• Primary Device ID: 00868390000204
• NIH Device Record Key: adb3e029-bc26-45c7-b58b-a01006cb9e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V2 ICE Probe SL
• Version Model Number: VP0601
• Catalog Number: VP0601
• Company DUNS: 831350785
• Company Name: SANARUS TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-909-3060
• Email: support@sanarus.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868390000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073533

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

Devices Manufactured by SANARUS TECHNOLOGIES, INC.

• 00868390000204 - V2 ICE Probe SL: 2018-07-06The 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.
• 00868390000204 - V2 ICE Probe SL: 2018-07-06 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
• 00868390000211 - Visica 2: 2018-07-06 The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable prob
• 00868390000228 - V2 ICE PROBE: 2018-07-06 The V2 ICE Probe is a single use, disposable probe designed for use with the Visica 2 Treatment System. The primary components