Endoskeleton™ TL Interbody System

GUDID 00191375052708

TRAY 1384-030-005 HL INSTRUMENTS SET 1

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable

• Primary Device ID: 00191375052708
• NIH Device Record Key: 648f035f-01c3-4d38-9ad8-20fb6c02d46e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TL Interbody System
• Version Model Number: 1384-030-005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375052708 [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

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-23
• Device Publish Date: 2024-08-15

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• 00763000879624 - Endoskeleton™ TCS Interbody System: 2024-12-09 EXTRACTOR 5210-1048 TCS BONE SCREW
• 00763000885151 - n/a: 2024-12-09 INSTRUMENT 2900250 SPREADER 6MM