OneRF Ablation System

GUDID 00856895008498

RF Ablation Generator

NEUROONE MEDICAL TECHNOLOGIES CORPORATION

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00856895008498
• NIH Device Record Key: 53cea536-7061-463e-8380-993a93d3791a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneRF Ablation System
• Version Model Number: NRFGN0001
• Company DUNS: 105937669
• Company Name: NEUROONE MEDICAL TECHNOLOGIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856895008498 [Primary]

FDA Product Code

• GXD: Generator, Lesion, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

On-Brand Devices [OneRF Ablation System]

• 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