| Primary Device ID | 00763000053369 |
| NIH Device Record Key | eb9e7c29-0cdd-44cc-af04-1fec4a68b5c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9733449 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000053369 [Primary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
[00763000053369]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
| 00643169618121 - O-arm | 2024-10-18 O-ARM SYS BI70002000 O2 UE 240V F DE DE |
| 00763000927141 - Medtronic | 2024-10-14 REF SET 9735501 SPINE REF REVISION |
| 00763000705008 - Stealth Autoguide | 2024-10-01 SYSTEM 29631 STEALTH AUTOGUIDE ENG ONLY |
| 00763000709631 - O-armTM O2 Imaging System | 2024-09-03 O-ARM SYS BI70002000 O2 UE 120V B EN UEN |
| 00763000521370 - VISUALASE | 2024-08-12 SYSTEM 9735542 15W VISUALASE |
| 00763000457365 - Medtronic Navigation | 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-E |
| 00763000457389 - Medtronic Navigation | 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SC |
| 00763000457402 - Medtronic Navigation | 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SE |