LandmarX

GUDID 00763000547110

FRAME 960361 LANDMARX FESS KIT

MEDTRONIC NAVIGATION, INC.

ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system 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.

• 20643169868131 - O-ARM®: 2024-04-15 MOUSE 9732721 STERILE O-ARM 10
• 00763000768744 - StealthStation S8: 2023-12-05 SW KIT 9735736 S8 2.1 ENT
• 00763000768867 - StealthStation S8: 2023-12-05 SW KIT 9735740 S8 2.1 SPINE
• 00763000768980 - StealthStation S8: 2023-12-05 SW KIT 9735919 S8 2.1 SPINE PLAN STATION
• 00763000769017 - StealthStation S8: 2023-12-05 SW KIT 9735920 S8 2.1 ENT PLAN STATION
• 00763000769123 - StealthStation S8: 2023-12-05 SW KIT 9736226 FLEX 2.1 ENT
• 00763000769192 - StealthStation S8: 2023-12-05 SW KIT 9736350 S8 2.1 AIR
• 00763000769208 - StealthStation S8: 2023-12-05 SFW KIT 9736186 STEALTH-MIDAS MR8