| Primary Device ID | 03701311501053 |
| NIH Device Record Key | 882d9589-6fd5-4077-89e2-468233b6b601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm |
| Version Model Number | A01019 |
| Company DUNS | 261610964 |
| Company Name | ECENTIAL ROBOTICS |
| 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 | 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 | 03701311501053 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-12 |
| Device Publish Date | 2023-09-04 |
| 03701311501374 - Patient Tracker SPX1 | 2023-12-25 |
| 03701311500940 - 3D Imaging Set SPX1 | 2023-09-14 |
| 03701311500704 - CoBot, Drill Bit | 2023-09-12 |
| 03701311500711 - CoBot, Drill Guide – Sleeve | 2023-09-12 |
| 03701311500728 - CoBot, Drill Guide – Cortical tip | 2023-09-12 |
| 03701311500735 - 3.5 mm Hex Head Screwdriver | 2023-09-12 |
| 03701311500742 - Fixation screw | 2023-09-12 |
| 03701311500759 - CoBot, Tool Holder | 2023-09-12 |