Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
- Device Name
- COOLIEF* Cooled Radiofrequency Probe Kit FDA UDI
- Model / Reference
- CRK-17-50-4 FDA UDI
- Description
- COOLIEF* Cooled Radiofrequency Probe Kit FDA UDI
Identifiers
- Catalog Number
- CRK-17-50-4 FDA UDI
- Primary DI / UDI-DI
- 00193493440757 FDA UDI
- 510(k) Number
- K053082 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Neurosurgical procedure kit, non-medicated, single-usePercutaneous radio-frequency ablation probe cannula, single-usePercutaneous radio-frequency ablation probe, denervation, monopolar, reusablePercutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053082 also covers:
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 923e40db-c6e0-4339-a6c2-6c3953ab599c 36 fields · synced Jun 9, 2026