Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- MCKA2-17-50-4 AVNS,MULTI-RF,RFQKIT,,17GX50,1 FDA UDI
- Model / Reference
- MCKA2-17-50-4 FDA UDI
- Description
- MCKA2-17-50-4 AVNS,MULTI-RF,RFQKIT,,17GX50,1 FDA UDI
Identifiers
- Catalog Number
- MCKA2-17-50-4 FDA UDI
- Primary DI / UDI-DI
- 00193493478910 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Neurosurgical procedure kit, non-medicated, 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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Neurosurgical procedure kit, non-medicated, single-usePercutaneous radio-frequency ablation probe cannula, single-usePercutaneous radio-frequency ablation probe, denervation, monopolar, single-usePercutaneous radio-frequency ablation probe, denervation, bipolar
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe, denervation, bipolar.
- OptaBlate — Stryker Corp. · Class II
- Intracept RF Probe — Relievant Medsystems, Inc. · Class II
- OptaBlate — Stryker Corp. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI aed054c2-9dff-4643-a558-522b5a18d0fd 35 fields · synced Jun 9, 2026