AxiEM™

GUDID 00643169425026

SHUNT KIT 9733606 SKULL MOUNTED

MEDTRONIC NAVIGATION, INC.

Stereotactic surgery system probe, single-use

• Primary Device ID: 00643169425026
• NIH Device Record Key: 1e00c30c-b1d5-4136-a2f0-0c93d1121872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxiEM™
• Version Model Number: 9733606
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169425026 [Primary]

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-13

On-Brand Devices [AxiEM™]

• 00613994394200: TUMOR RESECTION KIT 9733608 SKULL MOUNT
• 00613994394194: TUMOR RESECTION KIT 9733607 NON-INVASIVE
• 00613994394187: SHUNT KIT 9733606 SKULL MOUNTED
• 00613994394170: SHUNT KIT 9733605 NON-INVASIVE
• 00613994231031: SHUNT PACK 9733300 AXIEM NON-INVASIVE
• 00643169657694: SHUNT PK 9735650 NON INVASIVE EM INAV
• 00643169657687: TUMOR PK 9735649 NON INVASIVE EM INAV
• 00643169425026: SHUNT KIT 9733606 SKULL MOUNTED
• 00643169425019: SHUNT KIT 9733605 NON-INVASIVE
• 00885074403748: SW 9732243 CRANIAL APPLICATION INAV
• 00885074238241: PACK 9731975 TUMOR RESECTION AXIEM CR
• 00885074238227: SHUNT PACK 9731976 AXIEM SKULL MOUNTED
• 20643169632725: POINTER 9733424 TOUCH-N-GO AXIEM 5PK
• 20613994320227: POINTER 9733424 TOUCH-N-GO AXIEM 5PK
• 20613994320210: POINTER 9733423 TRACER AXIEM 5PK
• 00763000588489: STYLET 9735428 2 COIL SINGLE PACKAGE
• 00763000588472: PATIENT TRACKER 9735300 SKULL MOUNT PKGD
• 00763000588465: POINTER 9735319 NAVIGATION AXIEM PKGD
• 00763000588458: POINTER 9735318 TOUCH-N-GO AXIEM PKGD
• 00763000588441: POINTER 9735317 TRACER AXIEM PACKAGED
• 00763000588434: SUCTION 9735019 MALLEABLE STD TIP 12-FR
• 00763000588427: SUCTION 9735018 MALLEABLE BALL TIP 9-FR
• 00763000588410: SUCTION 9735017 MALLEABLE ANGLE TIP 9-FR
• 00763000588403: SUCTION 9735016 MALLEABLE STD TIP 9-FR
• 00763000588397: SUCTION 9735015 MALLEABLE STD TIP 7-FR
• 00763000588380: PATIENT TRACKER 9734887XOM NON-INVASIVE
• 00763000588373: TRACKER 9734887 NON-INVASIVE PATIENT
• 00763000588366: PATIENT TRACKER 9733534XOM ENT 1PK
• 00763000588359: PATIENT TRACKER 9733534 ENT 1 PK
• 00763000588342: INSTRUMENT TRACKER 9733533XOM ENT 1PK
• 00763000588335: INSTRUMENT TRACKER 9733533 ENT 1 PK
• 00763000738471: PATIENT TRACKER 9733534XOM ENT 1PK
• 00763000738457: INSTRUMENT TRACKER 9733533XOM ENT 1PK
• 00763000738426: PATIENT TRACKER 9734887XOM NON-INVASIVE
• 00763000738419: TRACKER 9734887 NON-INVASIVE PATIENT