| Primary Device ID | 00763000207632 |
| NIH Device Record Key | d227aedd-ebf9-4c22-9734-c33822245b40 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9735124 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000207632 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL 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 | 2020-04-06 |
| Device Publish Date | 2020-03-29 |
| 00763000521486 - Visualase V2 MRI-Guided Laser Ablation System | 2026-02-10 SYSTEM 9736422 VISUALASE V2 US ONLY |
| 00763000738488 - AxiEM™ | 2026-01-09 STYLET 9735428 2 COIL SINGLE PACKAGE |
| 00613994462428 - O-Arm | 2025-12-05 CONTROLLER 9733292R WIRELESS O-ARM RWK |
| 00763000255565 - N/A | 2025-09-29 TRIAL 9734663 CLYDESDALE 14X50MM |
| 00763000255589 - N/A | 2025-09-29 TRIAL 9734664 CLYDESDALE 14X55MM |
| 00199150014699 - NavLock™ | 2025-09-26 INST SET 9734492 SOLERA DEF UPGRADE |
| 00199150014729 - SOLERA | 2025-09-26 INST SET 9735284 SOLERA NONCAN TAPS |
| 00199150014736 - SOLERA | 2025-09-26 INST SET 9735285 SOLERA ILIAC TAPS A^ |