Prestige(R) Cervical Disc System

GUDID 00613994257314

CASE 6971419 PRESTIGE ST OUTER CASE

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray

• Primary Device ID: 00613994257314
• NIH Device Record Key: 62e4392a-3bf6-4bfd-bb86-f6f154733b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prestige(R) Cervical Disc System
• Version Model Number: 6971419
• 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: 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
• 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	00613994257314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

[00613994257314]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-11-27

On-Brand Devices [Prestige(R) Cervical Disc System]

• 00613994286970: LID 6961423 PRESTIGE SCREWS
• 00613994286963: CADDY 6961422 PRESTIGE SCREWS
• 00613994257338: CASE 6971421 PRESTIGE ST OUTER CASE LID
• 00613994257321: CASE 6971420 PRESTIGE ST INNER TRAY
• 00613994257314: CASE 6971419 PRESTIGE ST OUTER CASE