OneRF Ablation System

GUDID 00856895008566

Temperature Accessory / RF Connector Box

NEUROONE MEDICAL TECHNOLOGIES CORPORATION

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• Primary Device ID: 00856895008566
• NIH Device Record Key: 6fbd6990-0150-4815-ba49-02c0a839bd43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneRF Ablation System
• Version Model Number: NRFPK0001
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00856895008566 [Primary]

FDA Product Code

• GXD: Generator, Lesion, Radiofrequency

Sterilization

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

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