LandmarX

GUDID 00763000547110

FRAME 960361 LANDMARX FESS KIT

MEDTRONIC NAVIGATION, INC.

ENT stereotactic surgery system

• Primary Device ID: 00763000547110
• NIH Device Record Key: ddfb1ed5-65be-4684-b990-d5a102823ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LandmarX
• Version Model Number: 960361
• 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
• 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	00763000547110 [Primary]

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00763000547110]

Moist Heat or Steam Sterilization

[00763000547110]

Moist Heat or Steam Sterilization

[00763000547110]

Moist Heat or Steam Sterilization

[00763000547110]

Moist Heat or Steam Sterilization

[00763000547110]

Moist Heat or Steam Sterilization

[00763000547110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

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• 00613994462428 - O-Arm: 2025-12-05 CONTROLLER 9733292R WIRELESS O-ARM RWK
• 00763000255565 - N/A: 2025-09-29 TRIAL 9734663 CLYDESDALE 14X50MM
• 00763000255589 - N/A: 2025-09-29 TRIAL 9734664 CLYDESDALE 14X55MM
• 00199150014699 - NavLock™: 2025-09-26 INST SET 9734492 SOLERA DEF UPGRADE
• 00199150014729 - SOLERA: 2025-09-26 INST SET 9735284 SOLERA NONCAN TAPS
• 00199150014736 - SOLERA: 2025-09-26 INST SET 9735285 SOLERA ILIAC TAPS A^