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Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® System FDA UDI
- Generic Name
- Cryosurgical set FDA UDI
- Device Name
- Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template FDA UDI
- Model / Reference
- FPRPR3608 FDA UDI
- Description
- Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template FDA UDI
Identifiers
- Catalog Number
- FPRPR3608 FDA UDI
- Primary DI / UDI-DI
- 07290104831065 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
MR Unsafe FDA UDI
Category: Cryosurgical set
Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® System by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID
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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
- Boston Scientific
Sources (1)
- FDA UDI 476819fa-f850-4765-b6db-c050e6e3e127 37 fields · synced May 30, 2026