← Back to catalogue

OneRF Ablation System

FDA UDI

Class II (US FDA UDI)

by Neuroone Medical Technologies Corp.

Identity

Trade Name
OneRF Ablation System FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, brain-ablation FDA UDI
Device Name
68.5mm x 16 Contact sEEG - RF Probe FDA UDI
Model / Reference
NSEEG6916-RF FDA UDI
Description
68.5mm x 16 Contact sEEG - RF Probe FDA UDI

Identifiers

Primary DI / UDI-DI
00856895008641 FDA UDI
FDA Product Code
GXI FDA UDI
GZL FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, brain-ablation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4725 FDA UDI
882.1330 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
MRI Safety
MR Unsafe FDA UDI

Category: Depth electrodePercutaneous radio-frequency ablation probe, brain-ablation

OneRF Ablation System by Neuroone Medical Technologies Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe, brain-ablation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Neuroone Medical Technologies Corp.

Sources (1)

  • FDA UDI ac5f925f-48da-4ab5-bb17-53fe6adbea0a 34 fields · synced May 31, 2026