| Primary Device ID | 00643169966383 |
| NIH Device Record Key | 1cc57e02-a5cd-4c4a-b97a-09d99f9cb612 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9735734 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, 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 | 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 | true |
| 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 | 00643169966383 [Primary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169966383]
Moist Heat or Steam Sterilization
[00643169966383]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-08 |
| 00763000849320 - StealthStation Cranial | 2024-05-28 SWKT 9735586 STEALTH CRANIAL 3.1.5 |
| 00763000863302 - O-arm O2 | 2024-05-28 O-ARM SYS BI70002000 O2 UE 120V B EN UEN |
| 00763000616502 - O-arm O2 | 2024-05-06 O-ARM SYS BI70002000 O2 UE 240V H EN ENA^ |
| 00763000922405 - Medtronic | 2024-05-06 INST SET 9733935 CRANIAL PASSIVE |
| 20643169868131 - O-ARM® | 2024-04-15 MOUSE 9732721 STERILE O-ARM 10 |
| 00763000768744 - StealthStation S8 | 2023-12-05 SW KIT 9735736 S8 2.1 ENT |
| 00763000768867 - StealthStation S8 | 2023-12-05 SW KIT 9735740 S8 2.1 SPINE |
| 00763000768980 - StealthStation S8 | 2023-12-05 SW KIT 9735919 S8 2.1 SPINE PLAN STATION |