Catalyft PL Expandable Interbody System

GUDID 00763000246518

TRAY 6060003 CATALYFT PL NAV INNER TRAY

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00763000246518
• NIH Device Record Key: 9c31298a-3dc6-4df5-b5e2-258bedfa3042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyft PL Expandable Interbody System
• Version Model Number: 6060003
• 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
• 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
• 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	00763000246518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210425

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

[00763000246518]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-24
• Device Publish Date: 2021-06-16

On-Brand Devices [Catalyft PL Expandable Interbody System]

• 00763000292195: VERIFICATION TOOL NAV6061013 NAV INSERTR
• 00763000255299: TRIAL NAV6062116 CATALYFT PL40 NAV 11MM
• 00763000255282: TRIAL NAV6062096 CATALYFT PL40 NAV 9MM
• 00763000255275: TRIAL NAV6062076 CATALYFT PL40 NAV 7MM
• 00763000255268: TRIAL NAV6061116 CATALYFT PL NAV 11MM
• 00763000255251: TRIAL NAV6061096 CATALYFT PL NAV 9MM
• 00763000255244: TRIAL NAV6061076 CATALYFT PL NAV 7MM
• 00763000255237: INSERTER NAV6061000 CATALYFT PL NAV
• 00763000253554: DRIVER 6061002 CATALYFT PL INSERTER
• 00763000253547: INSERTER 6061001 CATALYFT PL INNER SLV
• 00763000253530: INSERTER 6061000 CATALYFT PL OUTER
• 00763000246853: SPACER 6069116 CATALYFT PL40 LONG 11MM
• 00763000246846: PACER 6069113 CATALYFT PL40 SHORT 11MM
• 00763000246822: SPACER 6069096 CATALYFT PL40 LONG 9MM
• 00763000246815: SPACER 6069093 CATALYFT PL40 SHORT 9MM
• 00763000246792: SPACER 6069076 CATALYFT PL40 LONG 7MM
• 00763000246785: SPACER 6069073 CATALYFT PL40 SHORT 7MM
• 00763000246761: SPACER 6068116 CATALYFT PL LONG 11MM
• 00763000246754: SPACER 6068113 CATALYFT PL SHORT 11MM
• 00763000246730: SPACER 6068096 CATALYFT PL LONG 9MM
• 00763000246723: SPACER 6068093 CATALYFT PL SHORT 9MM
• 00763000246709: SPACER 6068076 CATALYFT PL LONG 7MM
• 00763000246693: SPACER 6068073 CATALYFT PL SHORT 7MM
• 00763000246518: TRAY 6060003 CATALYFT PL NAV INNER TRAY
• 00763000239374: TRIAL 6062116 CATALYFT PL40 11MM
• 00763000239367: TRIAL 6062096 CATALYFT PL40 9MM
• 00763000239350: TRIAL 6062076 CATALYFT PL40 7MM
• 00763000239343: TRIAL 6061116 CATALYFT PL 11MM
• 00763000239336: TRIAL 6061096 CATALYFT PL 9MM
• 00763000239329: TRIAL 6061076 CATALYFT PL 7MM
• 00763000229221: TRAY 6060001 CATALYFT PL INSTRUMENTS
• 00763000229214: CASE 6060000 CATALYFT PL NAV INSTRUMENTS
• 00763000253615: AUGER 6061011 AUGER
• 00763000253608: HANDLE 6061009 RELEASE HANDLE
• 00763000253561: SLEEVE 6061003 EXTRACTOR SLEEVE
• 00763000253585: FUNNEL 6061005 INSERTER FUNNEL
• 00763000292188: ADAPTER 6061012 NAV TRIAL ADAPTER
• 00763000253578: PUSHER 6061004 INSERTER PUSHER