| Primary Device ID | 00856895008153 |
| NIH Device Record Key | 9f9d2494-cbae-4d78-9dd2-484275f62464 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One RF Ablation System |
| Version Model Number | NRFPK0001-TNRF |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856895008153 [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 | 2025-09-09 |
| Device Publish Date | 2025-09-01 |
| 00856895008146 | 16mm x 5 Contact Trigeminal RF Probe |
| 00856895008139 | 26.5mm x 8 Contact Trigeminal RF Probe |
| 00856895008153 | Trigeminal Nerve Temperature Accessory / RF Connector Box |