GUDID 00763000140243

COUNTERTORQUE 5580163 5.5/6.0

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument Orthopaedic counter-torque/rod-pushing instrument

• Primary Device ID: 00763000140243
• NIH Device Record Key: ad5da54f-bebd-45fb-80a4-820b67d6f6ce
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5580163
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000140243 [Primary]

FDA Product Code

• HXC: WRENCH

Sterilization

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

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

[00763000140243]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-07

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00643169597525 - CD HORIZON Spinal System: 2024-05-17 ROTATION ROD 652001500 500X5.5MM CCM PLS
• 00643169281110 - CD HORIZON® ASTUTE™ SPINAL SYSTEM: 2024-05-10 PEEK ROD 1608451035 6.0 X 6.9MM STR 35MM
• 00643169281264 - CD HORIZON® ASTUTE™ SPINAL SYSTEM: 2024-05-10 PEEK ROD 1608451090 6.0 X 6.9MM STR 90MM
• 00763000917982 - Medtronic Reusable Instruments: 2024-05-06 DEROTATOR EX0923006 APICAL 5.5/6.0
• 00763000919658 - Medtronic Reusable Instruments: 2024-05-06 RASP EX1023210 LS SMALL 12DEG 32X25X10MM
• 00763000919665 - Medtronic Reusable Instruments: 2024-05-06 RASP EX1023212 LS SMALL 12DEG 32X25X12MM
• 00763000919672 - Medtronic Reusable Instruments: 2024-05-06 RASP EX1023110 TL 12DEG 20W 10X60MM
• 00763000919689 - Medtronic Reusable Instruments: 2024-05-06 RASP EX1023112 TL 12DEG 20W 12X60MM