Identity
- Trade Name
- Warming System-unit, Cryosurgical FDA UDI
- Generic Name
- Cryosurgical set FDA UDI
- Model / Reference
- FPRMC00034 FDA UDI
Identifiers
- Catalog Number
- FPRMC00034 FDA UDI
- Primary DI / UDI-DI
- 07290016936223 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cryosurgical set
Warming System-unit, Cryosurgical by Uc-Care Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryosurgical set.
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- TempProbe™ — ENDOCARE, INC. · Class II
- IceSphere® 1.5 Cryoablation Needle — Boston Scientific · Class II
- IcePearl® 2.1 CX 90° Cryoablation Needle — Boston Scientific · Class II
- PerCryo™ — ENDOCARE, INC. · Class II
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
- Uc-Care Ltd
Sources (1)
- FDA UDI 6a6245d7-b8c8-4b89-94e7-b264d3abdb2a 33 fields · synced Jun 6, 2026