| Primary Device ID | 00763000531188 |
| NIH Device Record Key | 6af121f7-c77c-4af1-9cfe-423d4d731a29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SteathStation |
| Version Model Number | 9735736 |
| 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 | 00763000531188 [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 | 2022-02-07 |
| Device Publish Date | 2022-01-29 |
| 00763000531461 | SW KIT 9735740 STLTH S8 2.0 SPINE |
| 00763000532123 | SW 9735762 APP STLTH S8 V2.0 APP |
| 00763000532109 | SW KIT 9736226 2.0 STLTH FLEX ENT |
| 00763000532048 | SW KIT 9736350 2.0 STLTH AIR |
| 00763000531973 | SW KIT 9736025 S8 2.0 MICROSCOPE AUTO |
| 00763000531904 | SW KIT 9735921 S8 2.0 DBS STRT |
| 00763000531836 | SW KIT 9735920 S8 2.0 ENT PLAN STATION |
| 00763000531768 | SW KIT 9735919 S8 2.0 SPINE PLAN STATION |
| 00763000531690 | SW KIT 9735918 S8 2.0 STRTX 2NDLIC |
| 00763000531621 | SW KIT 9735917 S8 2.0 DBS 2ND LIC |
| 00763000531553 | SW KIT 9735916 S8 2.0 CRAN PLAN STATION |
| 00763000531546 | SW KIT 9735895 S8 STLTH LINK SET |
| 00763000531539 | SW KIT 9735744 S8 STLTHLINK |
| 00763000531393 | SW KIT 9735739 STLTH S8 2.0 STRTX |
| 00763000531324 | SW KIT 9735738 STLTH S8 2.0 CRN DBS |
| 00763000531256 | SW KIT 9735737 STLTH S8 2.0 CRAN |
| 00763000531188 | SW KIT 9735736 STLTH S8 2.0 ENT |
| 00763000539177 | SW KIT 9736426 S8 2.0 TRACTOG 2ND |
| 00763000539108 | SW KIT 9736423 S8 2.0 TRACTOG |
| 00763000539092 | SFW 9736420 STEALTH S8 TRACTOG |
| 00763000539238 | SW KIT 9736426 S8 2.0.1 TRACT 2ND EU-SC |