ATLAS® Cable System

GUDID 20673978047885

CABLE 826-012 DBL CBL WINTGL CRMPSS

MEDTRONIC SOFAMOR DANEK, INC.

Internal spinal fixation system cable, sterile

• Primary Device ID: 20673978047885
• NIH Device Record Key: f7d52cb3-85cc-4804-9315-49b1c254e213
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS® Cable System
• Version Model Number: 826-012
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 12
• 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: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978047881 [Unit of Use]
GS1	20673978047885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K892651

FDA Product Code

• LRN: Wire, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-25

On-Brand Devices [ATLAS® Cable System]

• 00673978048048: SNGL CABLE W/IC TI NON STERILE
• 00673978048024: CABLE 826-320 DBLE WIC TI NON STERILE
• 00673978048017: CABLE 826-219 DOUBLE LEADER TI
• 00673978047997: CRIMP 826-216 INTEGRAL BAR CRIMP TI
• 00673978047980: CABLE 826-213 SGL CBL WINTGRL CRMP TI
• 00673978047966: CABLE 826-211 DBL W INTEGRAL CRIMP TI
• 00673978047904: CRIMP 826-016 INTEGRAL BAR CRIMP SS
• 00673978047898: CABLE 826-013 SNGL CBL WINTGL CRMP SS
• 00673978047874: CABLE 826-011 DBL CBL WINTGL CRIMP SS
• 20673978048004: WASHER 826-217 FLAT BAR TI
• 20673978047977: CABLE 826-212 DBL CBL WINTGRL CRMP TI
• 20673978047885: CABLE 826-012 DBL CBL WINTGL CRMPSS
• 00673978047775: CASE 825-299 STERILIZATION
• 00673978047690: INSTRUMENT 825-210 CABLE TENSIONER