Identity
- Trade Name
- Cryoprobe D3.4 mm/10G, 285 mm, Pencil, Elliptic. FDA UDI
- Generic Name
- Hand-held cryosurgical system handpiece tip FDA UDI
- Device Name
- Cryoprobe-Use only with IceCure Cryogenic Device FDA UDI
- Model / Reference
- FAP7910000 FDA UDI
- Description
- Cryoprobe-Use only with IceCure Cryogenic Device FDA UDI
Identifiers
- Catalog Number
- FAP7910000 FDA UDI
- Primary DI / UDI-DI
- 07290015487108 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Hand-held cryosurgical system handpiece tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Cryoprobe D3.4 mm/10G, 285 mm, Pencil, Elliptic. by Icecure Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Icecure Medical Ltd
Sources (1)
- FDA UDI ea7e4f3f-dd99-4d90-8caf-1f37122d3487 37 fields · synced Jun 8, 2026