StealthStation S8

GUDID 00763000360504

MAIN CART 9735669 STEALTH S8 EM ENT

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system
Primary Device ID00763000360504
NIH Device Record Key5049ffff-4545-4624-868b-79e8971a8b45
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthStation S8
Version Model Number9735669
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 Batchfalse
Serial Numbertrue
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
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
GS100763000360504 [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 Date2021-06-28
Device Publish Date2021-06-18

On-Brand Devices [StealthStation S8]

00643169933866EM KIT 9735960 S8 ENT SIDE EMITTER
00643169933842EM KIT 9735958 S8 ENT UPG
00643169921931SFW KIT 9735917 S8 DBS 2ND LIC
00643169921924SFW KIT 9735918 S8 STEREOTX 2ND LIC
00643169919693EM KIT 9735956 S8 ENT ACC
00643169838918MAIN CART 9735669 STEALTH S8 EM ENT
00763000360504MAIN CART 9735669 STEALTH S8 EM ENT
00763000360498MAIN CART 9735669 STEALTH S8 EM ENT
00763000360481MAIN CART 9735669 STEALTH S8 EM ENT
00763000360474MAIN CART 9735669 STEALTH S8 EM ENT
00763000359942MAIN CART 9735668 STEALTH S8 CRANIAL
00763000359904MAIN CART 9735665 STEALTH S8 PREMIUM
00763000359874MAIN CART 9735665 STEALTH S8 PREMIUM
00763000359812MAIN CART 9735667 STEALTH S8 PLUS
00763000359775MAIN CART 9735667 STEALTH S8 PLUS
00763000355128CAMERA CART 9735670 STEALTH S8
00763000533090EM KIT 9735960 S8 ENT SIDE EMITTER
00763000852818SFW 9735762 APP STEALTH S8 V2.1
00763000769161SW KIT 9736426 S8 2.1 TRACTOG 2ND
00763000769130SW KIT 9736423 S8 2.1 TRACTOG
00763000769079SW KIT 9736025 S8 2.1 MICROSCOPE AUTO
00763000769048SW KIT 9735921 S8 2.1 DBS STRT
00763000768959SW KIT 9735918 S8 2.1 STRTX 2NDLIC
00763000768928SW KIT 9735917 S8 2.1 DBS 2ND LIC
00763000768898SW KIT 9735916 S8 2.1 CRAN PLAN STATION
00763000768836SW KIT 9735739 S8 2.1 STRTX
00763000768805SW KIT 9735738 S8 2.1 CRN DBS
00763000768775SW KIT 9735737 S8 2.1 CRAN
00763000769208SFW KIT 9736186 STEALTH-MIDAS MR8
00763000769192SW KIT 9736350 S8 2.1 AIR
00763000769123SW KIT 9736226 FLEX 2.1 ENT
00763000769017SW KIT 9735920 S8 2.1 ENT PLAN STATION
00763000768980SW KIT 9735919 S8 2.1 SPINE PLAN STATION
00763000768867SW KIT 9735740 S8 2.1 SPINE
00763000768744SW KIT 9735736 S8 2.1 ENT

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