Endoskeleton™ TCS Interbody System

GUDID 00763000406356

DRIVER 1000-0143 SHORT U-JOINT

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant driver

• Primary Device ID: 00763000406356
• NIH Device Record Key: cdd43d11-3e21-418d-94c1-761e24eff5ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TCS Interbody System
• Version Model Number: 1000-0143
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000406356 [Primary]

FDA Product Code

• HXX: SCREWDRIVER

Sterilization

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

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

[00763000406356]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [Endoskeleton™ TCS Interbody System]

• 00763000406356: DRIVER 1000-0143 SHORT U-JOINT
• 00763000879617: HANDLE 5210-1046 TCS RATCH TORQUE LIMIT
• 00763000879624: EXTRACTOR 5210-1048 TCS BONE SCREW
• 00763000879549: RONGEUR 5210-1015 TCS RONGEUR
• 00763000880378: DRIVER BIT 5210-1067-90 TCS HEX FIX ANGL
• 00763000880354: DRIVER ASSY 5210-1067-15 TCS FIX ANGLE
• 00763000880347: DRILL TIP 5210-1067-100 TCS FA DRV 2.5MM
• 00763000879570: MALLET 5210-1003 TCS MALLET
• 00763000880323: AWL GUIDE 5210-1073 TCS 15DG FIX BAY 2MM
• 00763000880316: HANDLE 5210-1068 TCS FIX ANGLE ANCILLARY
• 00763000879655: AWL 5210-1063 TCS CURVED FIXED 2MM
• 00763000879648: AWL 5210-1062 TCS STRAIGHT FIXED 2MM