GUDID 00763000047382

EMITTER 9735521R AXIEM 3 SIDE MOUNT

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000047382
• NIH Device Record Key: de323907-7ef5-4ce9-a302-3689e8ea00ca
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 9735521R
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000047382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162309

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: 2019-06-10
• Device Publish Date: 2019-06-01

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 00763000738334 - AxiEM™: 2026-02-23 POINTER 9735318 TOUCH-N-GO AXIEM PKGD
• 00763000738341 - AxiEM™: 2026-02-23 POINTER 9735317 TRACER AXIEM PACKAGED
• 00763000738358 - AxiEM™: 2026-02-23 SUCTION 9735019 MALLEABLE STD TIP 12-FR
• 00763000738365 - AxiEM™: 2026-02-23 SUCTION 9735018 MALLEABLE BALL TIP 9-FR
• 00763000738372 - AxiEM™: 2026-02-23 SUCTION 9735017 MALLEABLE ANGLE TIP 9-FR
• 00763000738389 - AxiEM™: 2026-02-23 SUCTION 9735016 MALLEABLE STD TIP 9-FR
• 00763000738396 - AxiEM™: 2026-02-23 SUCTION 9735015 MALLEABLE STD TIP 7-FR
• 00763000738402 - AxiEM™: 2026-02-23 PATIENT TRACKER 9735300 SKULL MOUNT PKGD