| Primary Device ID | 07640176970016 |
| NIH Device Record Key | c1d0a309-9d32-4ac4-9e95-5e75c3af0901 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigation unit |
| Version Model Number | NS001 |
| Company DUNS | 483929829 |
| Company Name | Naviswiss AG |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640176970016 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-24 |
| Device Publish Date | 2024-05-16 |
| 07640176971327 - Sizer Adapter | 2025-11-26 Instrument for surgical navigation. |
| 07640176970740 - Resection Checker | 2025-08-20 Surgical instrument to validate cuts |
| 07640176970016 - Navigation unit | 2024-05-24Navigation unit |
| 07640176970016 - Navigation unit | 2024-05-24 Navigation unit |
| 07640176970023 - Control unit | 2024-05-24 Control unit |
| 07640176970108 - Set of NAVItags (sterile, single-use) | 2024-05-24 Set of NAVItags (sterile, single-use) |
| 07640176970115 - Tag adapter P | 2024-05-24 Tag adapter P |
| 07640176970122 - Tag adapter M (magnetic) | 2024-05-24 Tag adapter M (magnetic) |
| 07640176970153 - Hex screwdriver SW3.5mm (AO coupling) | 2024-05-24 Hex screwdriver SW3.5mm (AO coupling) |