StealthStation Cranial Software

GUDID 00763000125295

SFW 9735762 APP STEALTH S8 APPLICATION

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system
Primary Device ID00763000125295
NIH Device Record Key556e89cf-4fd2-45f3-9e5a-4f0d38bb9f13
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthStation Cranial Software
Version Model Number9735762
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000125295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2018-07-30
Device Publish Date2018-06-29

On-Brand Devices [StealthStation Cranial Software]

00643169931329SFW KIT 9735916 S8 CRANIAL PLAN STATION
00643169921917SFW KIT 9735921 S8 DBS STEREOTX
00643169878211SFW 9735911 STEALTH S8 STEREOTAXY
00643169878204SFW 9735910 STEALTH S8 DBS
00643169865341SW APP 9735762 STEALTH S8 APP
00643169838987SFW KIT 9735739 STEALTH S8 STEREOTX
00643169838970SFW KIT 9735738 STEALTH S8 CRN DBS
00643169838963SW KIT 9735737 STEALTH S8 CRANIAL
00763000125295SFW 9735762 APP STEALTH S8 APPLICATION
00763000125004SFW KIT 9735739 STEALTH S8 STEREOTX
00763000124991SFW KIT 9735738 STEALTH S8 CRN DBS
00763000117009SFW KIT 9735737 STEALTH S8 CRANIAL
00763000116996SFW KIT 9735736 STEALTH S8 ENT
00763000075309SFW KIT 9735736 STEALTH S8 ENT
00763000075224SFW KIT 9735921 S8 DBS STEREOTX
00763000075170SFW KIT 9735916 S8 CRANIAL PLAN STATION
00763000075132SFW KIT 9735739 STEALTH S8 STEREOTX
00763000075125SFW KIT 9735738 STEALTH S8 CRN DBS
00763000075118SFW KIT 9735736 STEALTH S8 ENT EU-SW
00763000075101SFW KIT 9735736 STEALTH S8 ENT EU-SE
00763000075095SFW KIT 9735736 STEALTH S8 ENT EU-SC
00763000075088SFW KIT 9735736 STEALTH S8 ENT EU-SD
00763000075071SFW KIT 9735736 STEALTH S8 ENT EU-NW
00763000075064SFW KIT 9735736 STEALTH S8 ENT EU-E
00763000074951SFW KIT 9735737 STEALTH S8 CRANIAL EU-SE
00763000070625SFW KIT 9735737 STEALTH S8 CRANIAL
00763000238810SFW KIT 9735736 STEALTH S8 ENT
00763000234812SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW
00763000238650SFW KIT 9735739 STEALTH S8 STEREOTX
00763000238902SFW KIT 9735738 STEALTH S8 CRN DBS
00763000234867SFW 9735762 APP STEALTH S8 APPLICATION
00763000234799SFW KIT 9735737 STEALTH S8 CRANIAL
00763000378424SFW KIT 9735738 STEALTH S8 CRN DBS
00763000374167SFW KIT 9735737 STEALTH S8 CRANIAL
00763000373580SFW KIT 9735739 STEALTH S8 STEREOTX
00763000368494SFW 9735762 APP STEALTH S8 APPLICATION
00763000376215SFW KIT 9735736 STEALTH S8 ENT

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