GUDID 00763000855093

INSTRUMENT 6248464 14X16X14 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000855093
• NIH Device Record Key: dbe8ff42-3187-41dd-be8e-c5a2812548bb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6248464
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000855093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112444

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00199150066025 - Medtronic Reusable Instruments: 2026-03-03 DILATOR EX1125002 INITIAL LONG
• 00199150066032 - Medtronic Reusable Instruments: 2026-03-03 DILATOR EX1125003 INITIAL SHORT
• 00199150066049 - Medtronic Reusable Instruments: 2026-03-03 DILATOR EX1125004 INITIAL HANDLE
• 00199150002153 - N/A: 2026-03-02 COUNTERTRQUE 59325017 SIDE LOAD DOMINOES
• 00763000754624 - N/A: 2026-03-02 HMR,AXIAL&EXTENSION ROD TEMPLATE-5932501
• 00763000754631 - N/A: 2026-03-02 HELICOPTER TOOL 59325012 ROD REPLACEMENT
• 00763000754648 - N/A: 2026-03-02 HOLDER 59325001 STRAIGHT IMPLANT HOLDER
• 00763000754716 - N/A: 2026-03-02 HOLDER 59325002 ANGLED IMPLANT HOLDER