StealthStation® Cranial

GUDID 00763000517274

SWKT 9735586 STEALTH CRANIAL 3.1.3

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00763000517274
• NIH Device Record Key: 45ed35a6-ff83-42e1-90e7-583ac43b5ec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation® Cranial
• Version Model Number: 9735586
• 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
• 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	00763000517274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153660

FDA Product Code

• HAW: Neurological 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: 2021-05-31
• Device Publish Date: 2021-05-22

On-Brand Devices [StealthStation® Cranial]

• 00643169625631: SW KIT 9735587 STEALTH CRANIAL PLNG STN
• 00643169625570: SW KIT 9735586 STEALTHSTATION CRANIAL
• 00643169625532: SOFTWARE 9735585 STEALTHSTATION CRANIAL
• 00763000095819: SW KIT 9735587 STEALTH CRANIAL PLNG STN
• 00763000095758: SW KIT 9735586 STEALTHSTATION CRANIAL
• 00763000095741: SOFTWARE 9735585 STEALTHSTATION CRANIAL
• 00763000253165: SOFTWARE 9735585 STEALTHSTATION CRANIAL
• 00763000299972: SW KIT 9735586 STEALTHSTATION CRANIAL
• 00763000299927: SW KIT 9735587 STEALTH CRANIAL PLNG STN
• 00763000517335: SWKT 9735587 STLTH CRAN 3.1.3 PLNG STN
• 00763000517274: SWKT 9735586 STEALTH CRANIAL 3.1.3
• 00763000631826: SWKT 9735587 STLTH CRAN 3.1.4 PLNG STN
• 00763000631765: SWKT 9735586 STEALTH CRANIAL 3.1.4