| Primary Device ID | 00643169693616 |
| NIH Device Record Key | 0667c565-4088-494f-b85a-35c28fc8e462 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9735638 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 00643169693616 [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 |
| 00763000340339 - StealthStation | 2025-08-12 SW 9736041 STEALTHSTATION TOOLS DB |
| 00763000882440 - N/A | 2025-08-05 TAP 9734238 4.5 |
| 00763000882457 - NavLock™ | 2025-08-05 TAP 9734239 5.5 |
| 00763000882464 - N/A | 2025-08-05 TAP 9734240 6.5 |
| 00763000882471 - NavLock™ | 2025-08-05 TAP 9734282 4.0-4.5 AWL TIP |
| 00763000882495 - NavLock™ | 2025-08-05 TAP 9734284 5.5-6.5 AWL TIP |
| 00763000882501 - NavLock™ | 2025-08-05 TAP 9734285 6.5-7.5 AWL TIP |
| 00763000882532 - N/A | 2025-08-05 TAP 9734298 4.5 |