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Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FAP7400000
Identity
- Trade Name
- Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic EUDAMEDCryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic. FDA UDI
- Generic Name
- Hand-held cryosurgical system handpiece tip FDA UDI
- Device Name
- Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic EUDAMEDCryoprobe-Use only with IceCure Cryogenic Device FDA UDI
- Model / Reference
- FAP7400000 EUDAMEDFDA UDI
- Description
- Cryoprobe-Use only with IceCure Cryogenic Device FDA UDI
Identifiers
- Catalog Number
- FAP7400000 FDA UDI
- Primary DI / UDI-DI
- 07290015487092 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290015487092 EUDAMED
- 510(k) Number
- K183213 FDA UDI
- FDA Product Code
- GEH FDA UDI
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
- GMDN Term
- Hand-held cryosurgical system handpiece tip FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Shaft Length — 185 Millimeter FDA UDINeedle Gauge — 10 Gauge FDA UDI
Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic by Icecure Medical Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290015487092 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- IceCure Medical Ltd.
- EUDAMED SRN
- IL-MF-000026406
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED fd57e86f-1170-4bb0-9c3c-7a9a4606873e 61 fields · synced Aug 1, 2026
- FDA UDI 1ef81eec-2284-4eb9-a670-0e1fac75dfbc 37 fields · synced May 30, 2026