Medtronic Transportation/Sterilization Cassette

GUDID 00643169858794

TRAY 6978014 PRESTIGE LP STRMLN RASP US

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray

• Primary Device ID: 00643169858794
• NIH Device Record Key: 08c971ff-b0d4-4219-901a-ae6d1d4ea0ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Transportation/Sterilization Cassette
• Version Model Number: 6978014
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169858794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152241

FDA Product Code

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

Sterilization

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

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

[00643169858794]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-02-12

On-Brand Devices [Medtronic Transportation/Sterilization Cassette]

• 00643169858794: TRAY 6978014 PRESTIGE LP STRMLN RASP US
• 00643169858763: LOWER TRAY 6978013 PRESTIGE LP STRMLN US
• 00643169858756: UPPER TRAY 6978012 PRESTIGE LP STRMLN US
• 00643169792029: LID 5332023 CONTROLLER ACCESSORY CADDY
• 00643169792012: CADDY 5332022 CONTROLLER ACCESSORY
• 00643169792005: TRAY 5332021 CONTROLLER TRAY
• 00643169791992: TRAY 5332020 COUNTER TORQUE TRAY
• 00643169791985: TRAY 5332019 GENERAL INSTRUMENTS LOWER
• 00643169791978: TRAY 5332018 GENERAL INSTRUMENTS UPPER
• 00643169791923: 7068062 INSTRUMENT
• 00643169791916: 7068061 IMPLANT
• 00643169737310: TRAY 2159013 DISC PREP SUPPORT SET 2
• 00643169737303: TRAY 2159012 DISC PREP SUPPORT SET 1
• 00643169631731: TRAY 2159010 OLIF51 INSTRUMENTS
• 00643169631724: TRAY 2159009 OLIF ENDPLATE PREP
• 00643169631717: TRAY 2159008 OLIF COBBS AND SHAVERS
• 00643169631700: TRAY 2159007 OLIF INSTRUMENTS 2 OF 2
• 00643169631694: TRAY 2159006 OLIF INSTRUMENTS 1 OF 2
• 00643169628977: TRAY 7429002 RIALTO NAVIGATED INSTRUMENT
• 00643169731059: TRAY 7068060T IMPLANT INSTRUMENT 5.5/6.0