Identity
- Trade Name
- truFreeze FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introducer, 16 Fr CryoDecompression Tube (CDT), Dual Lumen, Connector, Suction Tubing and is used with the truFreeze Spray Cryotherapy System. FDA UDI
- Model / Reference
- 2000516 FDA UDI
- Description
- Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introducer, 16 Fr CryoDecompression Tube (CDT), Dual Lumen, Connector, Suction Tubing and is used with the truFreeze Spray Cryotherapy System. FDA UDI
Identifiers
- Catalog Number
- 2000516 FDA UDI
- Primary DI / UDI-DI
- 00724995199326 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
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
Yes
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 1fa359e3-3918-465e-b579-176f2cec5a90 37 fields · synced Jun 1, 2026