| Primary Device ID | 00643169862494 |
| NIH Device Record Key | e9676f41-8ed9-4103-9474-fe2d4d88bafa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigated Infinity ™ Instruments |
| Version Model Number | NAVNS3606010 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169862494 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169862494]
Moist Heat or Steam Sterilization
[00643169862494]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-08-02 |
| 00643169862494 | DRILL NAVNS3606010 2.4MM NAV NONSTERILE |
| 00643169862470 | TAP NAV3606055 5.0MM NAVIGATED |
| 00643169839663 | MODULE 3607037 NAVIGATED INSTRUMENT |
| 00643169778344 | GUIDE NAV3606006 DT NAVIGATION |
| 00643169725423 | TAP NAV3606030 3.0MM NAVIGATED |
| 00643169725461 | SCREWDRIVER NAV3606195 NAVIGATD THREADED |
| 00643169725454 | TAP NAV3606045 4.5MM NAVIGATED |
| 00643169725447 | TAP NAV3606040 4.0MM NAVIGATED |
| 00643169725430 | TAP NAV3606035 3.5MM NAVIGATED |