StealthStation® iNav w/ AxiEM™ TechNology

GUDID 00613994231383

SOFTWARE 9733260 AXIEM CRANIAL INAV

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00613994231383
• NIH Device Record Key: 0dd48665-9274-4a0d-bdc1-8dcd14c55f4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation® iNav w/ AxiEM™ TechNology
• Version Model Number: 9733260
• 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
• 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	00613994231383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001284

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-27

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 00763000738419 - AxiEM™: 2025-04-07 TRACKER 9734887 NON-INVASIVE PATIENT
• 00763000738426 - AxiEM™: 2025-04-07 PATIENT TRACKER 9734887XOM NON-INVASIVE
• 00763000738457 - AxiEM™: 2025-04-07 INSTRUMENT TRACKER 9733533XOM ENT 1PK
• 00763000738471 - AxiEM™: 2025-04-07 PATIENT TRACKER 9733534XOM ENT 1PK
• 00763000738495 - Aquamantys™: 2025-04-01 AQUAMANTYS 9.5 XL BIPOLAR SEALER DEVICE
• 00763000738501 - Aquamantys™: 2025-04-01 AQM 6.0 BIPOLAR SEALER UNIT
• 00763000738556 - Aquamantys™: 2025-04-01 AQUAMANTYS 2.3 BIPOLAR SEALER UNIT
• 00763000972318 - N/A: 2025-03-31 EMITTER 9733752R FLAT CALIBRATED