StealthStation

GUDID 00763000395360

SFW KIT 9735916 S8 CRANIAL PLAN STATION

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00763000395360
NIH Device Record Keyad50a575-713b-4b5c-a84a-74b6357958ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthStation
Version Model Number9735916
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]
GS100763000395360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-06

On-Brand Devices [StealthStation]

00643169984028SW 9736041 STEALTHSTATION TOOLS DB
00643169967007INTF KIT 9736028 LEICA PTR ONLY S8
00643169966994INTF KIT 9736027 LEICA HUD S8
00643169931343SFW KIT 9735920 S8 ENT PLAN STATION
00643169864658SFW KIT 9735895 S8 STEALTH LINK SET
00643169858428SW KIT 9735736 STEALTH S8 ENT
00643169839007SFW KIT 9735744 S8 STEALTHLINK
00763000134211SFW KIT 9736025 S8 MICROSCOPE AUTOPOS
00763000125202SFW KIT 9735736 STEALTH S8 ENT EU-NW
00763000125097SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW
00763000125073SFW KIT 9735921 S8 DBS STEREOTX
00763000125066SFW KIT 9735920 S8 ENT PLAN STATION
00763000125042SFW KIT 9735918 S8 STEREOTX 2ND LIC
00763000125035SFW KIT 9735917 S8 DBS 2ND LIC
00763000125028SFW KIT 9735916 S8 CRANIAL PLAN STATION
00763000075668SFW KIT 9735920 S8 ENT PLAN STAT EU-SE
00763000075651SFW KIT 9735920 S8 ENT PLAN STAT EU-E
00763000075644SFW KIT 9735920 S8 ENT PLAN STAT EU-SW
00763000075637SFW KIT 9735920 S8 ENT PLAN STAT EU-NW
00763000075293SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SE
00763000075286SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SC
00763000075279SFW KIT 9736025 S8 MICROSCOPE AUTOPOS
00763000075262SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-E
00763000075255SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SW
00763000075248SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SD
00763000075231SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-NW
00763000075217SFW KIT 9735920 S8 ENT PLAN STATION
00763000075194SFW KIT 9735918 S8 STEREOTX 2ND LIC
00763000075187SFW KIT 9735917 S8 DBS 2ND LIC
00763000075163SFW KIT 9735895 S8 STEALTH LINK SET
00763000075156SW KIT 9735744 S8 STEALTHLINK
00763000075019SFW KIT 9735920 S8 ENT PLAN STAT EU-SD
00763000071325KIT 9736094 S8 FPU ENT
00763000071318KIT 9736078 S8 FPU TUMOR RESECT NON-INV
00763000070830INTF KIT 9736027 LEICA HUD S8
00763000070762INTF KIT 9736028 LEICA PTR ONLY S8
00763000064730SFW KIT 9735920 S8 ENT PLAN STAT EU-SC
00763000063177SFW 9735762 APP STEALTH S8 APPLICATION
00763000063160KIT 9736082 S8 FPU SPINAL FUSION W O-ARM
00763000063122KIT 9736077 S8 FPU EM SHUNT NON-INVASIVE
00763000063108KIT 9736075 S8 FPU PASSIVE BIOPSY
00763000239084SFW KIT 9735921 S8 DBS STEREOTX
00763000234898SFW KIT 9736025 S8 MICROSCOPE AUTOPOS
00763000238988SFW KIT 9735918 S8 STEREOTX 2ND LIC
00763000234874SFW KIT 9735917 S8 DBS 2ND LIC
00763000238896SFW KIT 9735895 S8 STEALTH LINK SET
00763000238742SFW KIT 9735920 S8 ENT PLAN STATION
00763000319694INTF KIT 9736027 LEICA HUD S8
00763000234683SFW KIT 9735916 S8 CRANIAL PLAN STATION
00763000166618KIT 9736094 S8 FPU ENT

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