| Primary Device ID | 00856895008559 |
| NIH Device Record Key | ba3dd408-9fd3-4415-88c6-c0fada5c8f72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneRF Ablation System |
| Version Model Number | NRFCH0001 |
| 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 | true |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00856895008559 [Primary] |
| GXD | Generator, Lesion, Radiofrequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-25 |
| Device Publish Date | 2024-03-15 |
| 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 |