OneRF Ablation System

GUDID 00856895008641

Percutaneous radio-frequency ablation probe, brain-ablation

Primary Device ID	00856895008641
NIH Device Record Key	ac5f925f-48da-4ab5-bb17-53fe6adbea0a
Commercial Distribution Status	In Commercial Distribution
Brand Name	OneRF Ablation System
Version Model Number	NSEEG6916-RF
Company DUNS	105937669
Company Name	NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00856895008641 [Primary]

GXI	Probe, Radiofrequency Lesion

Steralize Prior To Use	false
Device Is Sterile	true

00856895008566	Temperature Accessory / RF Connector Box
00856895008559	Generator Accessory - Handle
00856895008535	Generator Accessory - Foot Pedal
00856895008528	Generator Accessory - Generator Interface Cable
00856895008511	Generator Accessory - Bin
00856895008504	Generator Accessory - Cart
00856895008498	RF Ablation Generator
00856895008658	80mm x 16 Contact sEEG - RF Probe
00856895008641	68.5mm x 16 Contact sEEG - RF Probe
00856895008634	61.5mm x 16 Contact sEEG - RF Probe