ATLAS® Cable System

GUDID 00673978048024

CABLE 826-320 DBLE WIC TI NON STERILE

MEDTRONIC SOFAMOR DANEK, INC.

Internal spinal fixation system cable, non-sterile

• Primary Device ID: 00673978048024
• NIH Device Record Key: 8a0ccd63-77bd-46f6-8882-c6d33701b23e
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ATLAS® Cable System
• Version Model Number: 826-320
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978048024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920201

FDA Product Code

• JDQ: CERCLAGE, FIXATION

Sterilization

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

[00673978048024]

Moist Heat or Steam Sterilization

[00673978048024]

Moist Heat or Steam Sterilization

[00673978048024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-12
• Device Publish Date: 2015-08-18

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