| Primary Device ID | 03701311500070 |
| NIH Device Record Key | 639d5bdf-0460-4044-9987-f33314edfbac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigation Set SPX1, Targeting Needle Bevel Tip - 11G, 125mm |
| Version Model Number | A00019 |
| 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 | true |
| 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 | 03701311500070 [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 | 2023-03-09 |
| Device Publish Date | 2023-03-01 |
| 03701311501497 - Op.n ChoiceSpine App | 2025-05-23 |
| 03701311500865 - Op.n Tracker A | 2025-03-28 |
| 03701311500872 - Op.n Tracker B | 2025-03-28 |
| 03701311500889 - Op.n Tracker C | 2025-03-28 |
| 03701311500896 - Op.n Tracker D | 2025-03-28 |
| 03701311500902 - Navigation Instrument tray | 2025-03-28 |
| 03701311501275 - Op.n Camera | 2025-03-28 |
| 03701311501282 - Tracker fixation screw | 2025-03-28 |