| Primary Device ID | 00856895008375 |
| NIH Device Record Key | f47a3a6a-15fe-4a33-812d-09efd4ca0c8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVO Cable Assembly |
| Version Model Number | EVO Cable Assembly |
| Catalog Number | NEC1602 |
| 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 | 00856895008375 [Primary] |
| GZL | Electrode, Depth |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-05 |
| Device Publish Date | 2021-09-27 |
| 00856895008153 - One RF Ablation System | 2025-09-09 Trigeminal Nerve Temperature Accessory / RF Connector Box |
| 00856895008139 - One RF Ablation System | 2025-08-28 26.5mm x 8 Contact Trigeminal RF Probe |
| 00856895008146 - One RF Ablation System | 2025-08-28 16mm x 5 Contact Trigeminal RF Probe |
| 00856895008634 - OneRF Ablation System | 2024-12-10 61.5mm x 16 Contact sEEG - RF Probe |
| 00856895008641 - OneRF Ablation System | 2024-12-10 68.5mm x 16 Contact sEEG - RF Probe |
| 00856895008658 - OneRF Ablation System | 2024-12-10 80mm x 16 Contact sEEG - RF Probe |
| 00856895008498 - OneRF Ablation System | 2024-03-25 RF Ablation Generator |
| 00856895008504 - OneRF Ablation System | 2024-03-25 Generator Accessory - Cart |