Identity
- Trade Name
- V2 ICE Probe SL FDA UDI
- Generic Name
- Cryosurgical set FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- VP0601 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- VP0601 FDA UDI
- Primary DI / UDI-DI
- 00868390000204 FDA UDI
- 510(k) Number
- K073533 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryosurgical set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cryosurgical set
V2 ICE Probe SL by Sanarus Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sanarus Technologies, Inc.
Sources (1)
- FDA UDI adb3e029-bc26-45c7-b58b-a01006cb9e1f 37 fields · synced Jun 8, 2026