| Primary Device ID | 00763000768980 |
| NIH Device Record Key | 7c8e6723-ea02-41d1-97f4-476cfd4ee38c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StealthStation S8 |
| Version Model Number | 9735919 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000768980 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-05 |
| Device Publish Date | 2023-11-27 |
| 00643169933866 | EM KIT 9735960 S8 ENT SIDE EMITTER |
| 00643169933842 | EM KIT 9735958 S8 ENT UPG |
| 00643169921931 | SFW KIT 9735917 S8 DBS 2ND LIC |
| 00643169921924 | SFW KIT 9735918 S8 STEREOTX 2ND LIC |
| 00643169919693 | EM KIT 9735956 S8 ENT ACC |
| 00643169838918 | MAIN CART 9735669 STEALTH S8 EM ENT |
| 00763000360504 | MAIN CART 9735669 STEALTH S8 EM ENT |
| 00763000360498 | MAIN CART 9735669 STEALTH S8 EM ENT |
| 00763000360481 | MAIN CART 9735669 STEALTH S8 EM ENT |
| 00763000360474 | MAIN CART 9735669 STEALTH S8 EM ENT |
| 00763000359942 | MAIN CART 9735668 STEALTH S8 CRANIAL |
| 00763000359904 | MAIN CART 9735665 STEALTH S8 PREMIUM |
| 00763000359874 | MAIN CART 9735665 STEALTH S8 PREMIUM |
| 00763000359812 | MAIN CART 9735667 STEALTH S8 PLUS |
| 00763000359775 | MAIN CART 9735667 STEALTH S8 PLUS |
| 00763000355128 | CAMERA CART 9735670 STEALTH S8 |
| 00763000533090 | EM KIT 9735960 S8 ENT SIDE EMITTER |
| 00763000852818 | SFW 9735762 APP STEALTH S8 V2.1 |
| 00763000769161 | SW KIT 9736426 S8 2.1 TRACTOG 2ND |
| 00763000769130 | SW KIT 9736423 S8 2.1 TRACTOG |
| 00763000769079 | SW KIT 9736025 S8 2.1 MICROSCOPE AUTO |
| 00763000769048 | SW KIT 9735921 S8 2.1 DBS STRT |
| 00763000768959 | SW KIT 9735918 S8 2.1 STRTX 2NDLIC |
| 00763000768928 | SW KIT 9735917 S8 2.1 DBS 2ND LIC |
| 00763000768898 | SW KIT 9735916 S8 2.1 CRAN PLAN STATION |
| 00763000768836 | SW KIT 9735739 S8 2.1 STRTX |
| 00763000768805 | SW KIT 9735738 S8 2.1 CRN DBS |
| 00763000768775 | SW KIT 9735737 S8 2.1 CRAN |
| 00763000769208 | SFW KIT 9736186 STEALTH-MIDAS MR8 |
| 00763000769192 | SW KIT 9736350 S8 2.1 AIR |
| 00763000769123 | SW KIT 9736226 FLEX 2.1 ENT |
| 00763000769017 | SW KIT 9735920 S8 2.1 ENT PLAN STATION |
| 00763000768980 | SW KIT 9735919 S8 2.1 SPINE PLAN STATION |
| 00763000768867 | SW KIT 9735740 S8 2.1 SPINE |
| 00763000768744 | SW KIT 9735736 S8 2.1 ENT |