StealthStation® AXIEM™ System

GUDID 00763000241483

AXIEM KIT 9732750 PORTABLE PRE-BUILD

MEDTRONIC NAVIGATION, INC.

Stereotactic surgery system workstation

• Primary Device ID: 00763000241483
• NIH Device Record Key: bc99a2d7-fda0-444a-9c77-9b6e00476b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation® AXIEM™ System
• Version Model Number: 9732750
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000241483 [Primary]

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: 2019-03-11
• Device Publish Date: 2019-02-21

On-Brand Devices [StealthStation® AXIEM™ System]

• 00613994109477: AXIEM KIT, 9732750, PORTABLE PRE-BUILD
• 00763000241483: AXIEM KIT 9732750 PORTABLE PRE-BUILD