StealthStation

GUDID 00763000075286

SFW KIT 9736025 S8 MCRSCP AUTOPOS EU-SC

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000075286
• NIH Device Record Key: 513c3e5f-4b1d-46d4-994b-b80dd5bbc77d
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000075286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162309

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-25

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