Duns Number:831350785
Device Description: The V2 ICE Probe is a single use, disposable probe designed for use with the Visica 2 Trea The V2 ICE Probe 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.
Catalog Number
VP0600
Brand Name
V2 ICE PROBE
Version/Model Number
VP0600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062896
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
3868c1af-f3e8-4669-9bfe-498d65e0b2de
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |