| Primary Device ID | 00856895008634 |
| NIH Device Record Key | 718f733f-a074-49f5-b52a-faa9d78b117e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneRF Ablation System |
| Version Model Number | NSEEG6216-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 |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com | |
| Phone | 952-426-1383 |
| CustomerService@N1MTC.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856895008634 [Primary] |
| GXI | Probe, Radiofrequency Lesion |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-10 |
| Device Publish Date | 2024-12-02 |
| 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 |