Identity
- Trade Name
- truFreeze FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- truFreeze Spray Cryotherapy Console - Evaluation Unit FDA UDI
- Model / Reference
- CC301E FDA UDI
- Description
- truFreeze Spray Cryotherapy Console - Evaluation Unit FDA UDI
Identifiers
- Catalog Number
- CC301E FDA UDI
- Primary DI / UDI-DI
- 00724995199302 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical 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
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, mechanical
truFreeze by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General cryosurgical system, cryogen gas, mechanical.
- AtriCure cryoICE cryoSPHERE Cryoablation System — ATRICURE, INC. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- CryoProbe™ — H & O Equipments SA · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- Wallach — CooperSurgical, Inc. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
Cleared under the same submission
K171626 also covers:
K222272 also covers:
K223369 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI 9a7d88a5-8c9c-4b91-92e4-e8225995387d 36 fields · synced May 30, 2026