Medtronic Cases and Trays

GUDID 00763000654566

TRAY 5598919 LOCKING HEAD INSERTER UPPER

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00763000654566
• NIH Device Record Key: 1c93e1bf-bcf1-495a-8dda-717e655169b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Cases and Trays
• Version Model Number: 5598919
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000654566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

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

Sterilization

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

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

[00763000654566]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-22
• Device Publish Date: 2023-08-14

On-Brand Devices [Medtronic Cases and Trays]

• 00763000654573: TRAY 5598920 LOCKING HEAD INSERTER LOWER
• 00763000654566: TRAY 5598919 LOCKING HEAD INSERTER UPPER
• 00763000761134: TRAY RBT090100 ROBOTIC GRAFT DELIVERY
• 00721902957093: CASE 7059532 LEG STANDARD HOOK MOD TI