Identity
- Trade Name
- Cerene Cryotherapy Device FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, electronic FDA UDI
- Model / Reference
- FGS-7000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008595035 FDA UDI
- PMA Number
- P180032 FDA UDI
- FDA Product Code
- MNB FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, electronic FDA UDI
Classification
- Device Class
- Class III 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
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: General cryosurgical system, cryogen gas, electronic
Cerene Cryotherapy Device by Channel Medsystems, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Channel Medsystems, Inc.
Sources (1)
- FDA UDI 17af5448-366c-4141-a382-3d959ce6bd5b 34 fields · synced May 30, 2026