StealthStation Cranial

GUDID 00763000849320

SWKT 9735586 STEALTH CRANIAL 3.1.5

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00763000849320
• NIH Device Record Key: 412dd3ed-e85a-4769-913d-586decbb7126
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000849320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231976

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: 2024-05-28
• Device Publish Date: 2024-05-20

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 00643169618121 - O-arm: 2024-10-18 O-ARM SYS BI70002000 O2 UE 240V F DE DE
• 00763000927141 - Medtronic: 2024-10-14 REF SET 9735501 SPINE REF REVISION
• 00763000705008 - Stealth Autoguide: 2024-10-01 SYSTEM 29631 STEALTH AUTOGUIDE ENG ONLY
• 00763000709631 - O-armTM O2 Imaging System: 2024-09-03 O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00763000521370 - VISUALASE: 2024-08-12 SYSTEM 9735542 15W VISUALASE
• 00763000457365 - Medtronic Navigation: 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-E
• 00763000457389 - Medtronic Navigation: 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SC
• 00763000457402 - Medtronic Navigation: 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SE