LOOP ® SPINAL SYSTEM

GUDID 00643169398757

TRIAL 25700061 IMPACTOR

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169398757
• NIH Device Record Key: 860e884c-4d20-4d68-b4bb-22b2da6441ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOOP ® SPINAL SYSTEM
• Version Model Number: 25700061
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169398757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121332

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

[00643169398757]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-21

On-Brand Devices [LOOP ® SPINAL SYSTEM]

• 00643169398771: ADAPTER 25700211 CAP
• 00643169398764: INSERTER 25700021 TUBE
• 00643169398757: TRIAL 25700061 IMPACTOR
• 00643169241855: INSERTER 2570002 LOOP INSERTER TUBE