| Primary Device ID | 00643169691964 |
| NIH Device Record Key | ebe5d26c-3657-4797-b7a5-57a60d9aa491 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9735680 |
| 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 | 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 | 00643169691964 [Primary] |
| PGW | Ear, Nose, and Throat Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
| 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 |
| 00763000769017 - StealthStation S8 | 2023-12-05 SW KIT 9735920 S8 2.1 ENT PLAN STATION |
| 00763000769123 - StealthStation S8 | 2023-12-05 SW KIT 9736226 FLEX 2.1 ENT |
| 00763000769192 - StealthStation S8 | 2023-12-05 SW KIT 9736350 S8 2.1 AIR |
| 00763000769208 - StealthStation S8 | 2023-12-05 SFW KIT 9736186 STEALTH-MIDAS MR8 |