Medtronic Transportation/Sterilization Cassette

GUDID 00643169858794

TRAY 6978014 PRESTIGE LP STRMLN RASP US

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• 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