Identity
- Trade Name
- One RF Ablation System FDA UDI
- Generic Name
- Facial nerve-locating system FDA UDI
- Device Name
- 16mm x 5 Contact Trigeminal RF Probe FDA UDI
- Model / Reference
- 1605-TNRF FDA UDI
- Description
- 16mm x 5 Contact Trigeminal RF Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856895008146 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Facial nerve-locating system 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
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Percutaneous radio-frequency ablation probe cannula, single-useFacial nerve-locating system
One RF Ablation System by Neuroone Medical Technologies Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Facial nerve-locating system.
- Hilger Dual Stim — WR Medical Electronics Co. · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Silverstein Facial Nerve Stimulator — WR Medical Electronics Co. · Class II
- One RF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
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 |
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Manufacturer
- Manufacturer
- Neuroone Medical Technologies Corp.
Sources (1)
- FDA UDI 472c82ea-b046-416b-b7d4-82d59946b59a 34 fields · synced May 30, 2026