| Primary Device ID | 17290114061466 |
| NIH Device Record Key | 1a3a40bc-de01-4216-b24a-7dc112064795 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroSmart / NeuroNav LeadConfirm A Adaptor |
| Version Model Number | NeuroSmart / NeuroNav LeadConfirm A Adaptor |
| Catalog Number | STR-000077-00 |
| Company DUNS | 531856466 |
| Company Name | ALPHA OMEGA ENGINEERING CO. LTD. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07290114061469 [Primary] |
| GS1 | 17290114061466 [Package] Contains: 07290114061469 Package: Carton [10 Units] In Commercial Distribution |
| 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 | 2022-06-15 |
| Device Publish Date | 2022-06-07 |
| 07290114064057 - Remote Control | 2024-01-12 |
| 07290114064064 - Remote Control | 2024-01-12 |
| 07290114064071 - HaGuide Software | 2024-01-09 |
| 07290114064149 - Bengun W/O Screws | 2024-01-09 |
| 07290114064156 - Bengun Adapter | 2024-01-09 |
| 07290014954083 - NeuroSmart Main Unit | 2024-01-08 |
| 07290016450019 - NeuroSmart MER Headstage | 2024-01-08 |
| 07290114060790 - NeuroSmart NeuroForits Drive Headstage | 2024-01-08 |