GUDID 00763000140212

SLEEVE 5580160 TYPE A 5.5/6.0

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic surgical distractor, internal

• Primary Device ID: 00763000140212
• NIH Device Record Key: b50c3ea2-b347-4f33-9991-c32d20bb4aa6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5580160
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000140212 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

[00763000140212]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-06
• Device Publish Date: 2021-11-26

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000764050 - OsteoCool™ 2.0 RF Ablation System: 2024-11-19 CART OCA01-100 OC 2.0 100W STAND
• 00763000670542 - n/a: 2024-11-18 TEMPLATE 3005975 ZEVO 75MM 5 LVL
• 00763000670559 - n/a: 2024-11-18 TEMPLATE 3005977 ZEVO 77MM 5 LVL
• 00763000670566 - n/a: 2024-11-18 TEMPLATE 3005979 ZEVO 79MM 5 LVL
• 00763000670573 - n/a: 2024-11-18 TEMPLATE 3005981 ZEVO 81MM 5 LVL
• 00763000670580 - n/a: 2024-11-18 TEMPLATE 3005985 ZEVO 85MM 5 LVL
• 00763000670597 - n/a: 2024-11-18 TEMPLATE 3005990 ZEVO 90MM 5 LVL
• 00763000670603 - n/a: 2024-11-18 TEMPLATE 3005995 ZEVO 95MM 5 LVL