StealthStation S8 Platform

GUDID 00763000403867

S8 MAIN SYSTEM REFURB 9735665R

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000403867
• NIH Device Record Key: 1e559177-78a5-4c10-9983-c3330e47d609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation S8 Platform
• Version Model Number: 9735665R
• 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: false
• Serial Number: true
• 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
• 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	00763000403867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162309

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: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [StealthStation S8 Platform]

• 00643169933859: EM KIT 9735959 S8 FLAT EMITTER
• 00643169933835: EM KIT 9735957 S8 CRANIAL UPG
• 00643169919709: EM KIT 9735955 S8 CRANIAL ACC
• 00643169877016: MAIN CART 9735668 S8 EM CRANIAL
• 00643169876972: MAIN CART 9735667 STEALTH S8 PLUS
• 00643169876934: MAIN CART 9735666 STEALTH S8 BASIC
• 00643169722194: CAMERA CART 9735670 STEALTH S8 BASIC
• 00643169722187: MAIN CART 9735665 STEALTH S8 PREMIUM
• 00763000208479: EM KIT 9735955 S8 CRANIAL ACC
• 00763000272791: MAIN CART 9735667 STEALTH S8 PLUS
• 00763000272739: MAIN CART 9735665 STEALTH S8 PREMIUM
• 00763000272760: MAIN CART 9735665 STEALTH S8 PREMIUM
• 00763000360467: MAIN CART 9735669 STEALTH S8 EM ENT
• 00763000360450: MAIN CART 9735669 STEALTH S8 EM ENT
• 00763000360399: MAIN CART 9735666 STEALTH S8 BASIC
• 00763000360382: MAIN CART 9735666 STEALTH S8 BASIC
• 00763000359935: MAIN CART 9735668 STEALTH S8 CRANIAL
• 00763000359928: MAIN CART 9735668 STEALTH S8 CRANIAL
• 00763000359898: MAIN CART 9735665 STEALTH S8 PREMIUM
• 00763000359881: MAIN CART 9735665 STEALTH S8 PREMIUM
• 00763000359799: MAIN CART 9735667 STEALTH S8 PLUS
• 00763000359782: MAIN CART 9735667 STEALTH S8 PLUS
• 00763000403867: S8 MAIN SYSTEM REFURB 9735665R
• 00763000401191: S8 CAMERA SYSTEM REFURB 9735670R