StealthStation
GUDID 00763000376055
SFW KIT 9736025 S8 MICROSCOPE AUTOPOS
MEDTRONIC NAVIGATION, INC.
Multi-purpose stereotactic surgery system| Primary Device ID | 00763000376055 |
| NIH Device Record Key | 5fae7e25-f320-4184-af75-987b5325edf9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StealthStation |
| Version Model Number | 9736025 |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000376055 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201175
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-21 |
| Device Publish Date | 2020-09-12 |
On-Brand Devices [StealthStation]
| 00643169984028 | SW 9736041 STEALTHSTATION TOOLS DB |
| 00643169967007 | INTF KIT 9736028 LEICA PTR ONLY S8 |
| 00643169966994 | INTF KIT 9736027 LEICA HUD S8 |
| 00643169931343 | SFW KIT 9735920 S8 ENT PLAN STATION |
| 00643169864658 | SFW KIT 9735895 S8 STEALTH LINK SET |
| 00643169858428 | SW KIT 9735736 STEALTH S8 ENT |
| 00643169839007 | SFW KIT 9735744 S8 STEALTHLINK |
| 00763000134211 | SFW KIT 9736025 S8 MICROSCOPE AUTOPOS |
| 00763000125202 | SFW KIT 9735736 STEALTH S8 ENT EU-NW |
| 00763000125097 | SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW |
| 00763000125073 | SFW KIT 9735921 S8 DBS STEREOTX |
| 00763000125066 | SFW KIT 9735920 S8 ENT PLAN STATION |
| 00763000125042 | SFW KIT 9735918 S8 STEREOTX 2ND LIC |
| 00763000125035 | SFW KIT 9735917 S8 DBS 2ND LIC |
| 00763000125028 | SFW KIT 9735916 S8 CRANIAL PLAN STATION |
| 00763000075668 | SFW KIT 9735920 S8 ENT PLAN STAT EU-SE |
| 00763000075651 | SFW KIT 9735920 S8 ENT PLAN STAT EU-E |
| 00763000075644 | SFW KIT 9735920 S8 ENT PLAN STAT EU-SW |
| 00763000075637 | SFW KIT 9735920 S8 ENT PLAN STAT EU-NW |
| 00763000075293 | SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SE |
| 00763000075286 | SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SC |
| 00763000075279 | SFW KIT 9736025 S8 MICROSCOPE AUTOPOS |
| 00763000075262 | SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-E |
| 00763000075255 | SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SW |
| 00763000075248 | SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SD |
| 00763000075231 | SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-NW |
| 00763000075217 | SFW KIT 9735920 S8 ENT PLAN STATION |
| 00763000075194 | SFW KIT 9735918 S8 STEREOTX 2ND LIC |
| 00763000075187 | SFW KIT 9735917 S8 DBS 2ND LIC |
| 00763000075163 | SFW KIT 9735895 S8 STEALTH LINK SET |
| 00763000075156 | SW KIT 9735744 S8 STEALTHLINK |
| 00763000075019 | SFW KIT 9735920 S8 ENT PLAN STAT EU-SD |
| 00763000071325 | KIT 9736094 S8 FPU ENT |
| 00763000071318 | KIT 9736078 S8 FPU TUMOR RESECT NON-INV |
| 00763000070830 | INTF KIT 9736027 LEICA HUD S8 |
| 00763000070762 | INTF KIT 9736028 LEICA PTR ONLY S8 |
| 00763000064730 | SFW KIT 9735920 S8 ENT PLAN STAT EU-SC |
| 00763000063177 | SFW 9735762 APP STEALTH S8 APPLICATION |
| 00763000063160 | KIT 9736082 S8 FPU SPINAL FUSION W O-ARM |
| 00763000063122 | KIT 9736077 S8 FPU EM SHUNT NON-INVASIVE |
| 00763000063108 | KIT 9736075 S8 FPU PASSIVE BIOPSY |
| 00763000239084 | SFW KIT 9735921 S8 DBS STEREOTX |
| 00763000234898 | SFW KIT 9736025 S8 MICROSCOPE AUTOPOS |
| 00763000238988 | SFW KIT 9735918 S8 STEREOTX 2ND LIC |
| 00763000234874 | SFW KIT 9735917 S8 DBS 2ND LIC |
| 00763000238896 | SFW KIT 9735895 S8 STEALTH LINK SET |
| 00763000238742 | SFW KIT 9735920 S8 ENT PLAN STATION |
| 00763000319694 | INTF KIT 9736027 LEICA HUD S8 |
| 00763000234683 | SFW KIT 9735916 S8 CRANIAL PLAN STATION |
| 00763000166618 | KIT 9736094 S8 FPU ENT |
Trademark Results [StealthStation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEALTHSTATION 75025042 2191709 Live/Registered |
MEDTRONIC NAVIGATION, INC. 1995-11-28 |
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