SteathStation

GUDID 00763000531461

SW KIT 9735740 STLTH S8 2.0 SPINE

MEDTRONIC NAVIGATION, INC.

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• Primary Device ID: 00763000531461
• NIH Device Record Key: 810fe6b8-c6a7-46b6-a103-bb204d828f5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteathStation
• Version Model Number: 9735740
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000531461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203639

FDA Product Code

• OLO: Orthopedic 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: 2022-02-04
• Device Publish Date: 2022-01-27

On-Brand Devices [SteathStation]

• 00763000531461: SW KIT 9735740 STLTH S8 2.0 SPINE
• 00763000532123: SW 9735762 APP STLTH S8 V2.0 APP
• 00763000532109: SW KIT 9736226 2.0 STLTH FLEX ENT
• 00763000532048: SW KIT 9736350 2.0 STLTH AIR
• 00763000531973: SW KIT 9736025 S8 2.0 MICROSCOPE AUTO
• 00763000531904: SW KIT 9735921 S8 2.0 DBS STRT
• 00763000531836: SW KIT 9735920 S8 2.0 ENT PLAN STATION
• 00763000531768: SW KIT 9735919 S8 2.0 SPINE PLAN STATION
• 00763000531690: SW KIT 9735918 S8 2.0 STRTX 2NDLIC
• 00763000531621: SW KIT 9735917 S8 2.0 DBS 2ND LIC
• 00763000531553: SW KIT 9735916 S8 2.0 CRAN PLAN STATION
• 00763000531546: SW KIT 9735895 S8 STLTH LINK SET
• 00763000531539: SW KIT 9735744 S8 STLTHLINK
• 00763000531393: SW KIT 9735739 STLTH S8 2.0 STRTX
• 00763000531324: SW KIT 9735738 STLTH S8 2.0 CRN DBS
• 00763000531256: SW KIT 9735737 STLTH S8 2.0 CRAN
• 00763000531188: SW KIT 9735736 STLTH S8 2.0 ENT
• 00763000539177: SW KIT 9736426 S8 2.0 TRACTOG 2ND
• 00763000539108: SW KIT 9736423 S8 2.0 TRACTOG
• 00763000539092: SFW 9736420 STEALTH S8 TRACTOG
• 00763000539238: SW KIT 9736426 S8 2.0.1 TRACT 2ND EU-SC