LOOP® Spinal System

GUDID 00643169241794

TRIAL 2570010 LOOP VARIABLE TRIAL 10MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00643169241794
• NIH Device Record Key: 00b38247-215a-44c2-b9e0-0811f888e458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOOP® Spinal System
• Version Model Number: 2570010
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169241794 [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

[00643169241794]

Moist Heat or Steam Sterilization

[00643169241794]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-07-01

On-Brand Devices [LOOP® Spinal System]

• 00643169241848: INSERTER 2570003 LOOP INSERTER SHAFT
• 00643169241817: TRIAL 2570008 LOOP VARIABLE TRIAL 8MM
• 00643169241800: TRIAL 2570009 LOOP VARIABLE TRIAL 9MM
• 00643169241794: TRIAL 2570010 LOOP VARIABLE TRIAL 10MM
• 00643169241787: TRIAL 2570011 LOOP VARIABLE TRIAL 11MM
• 00643169241770: TRIAL 2570012 LOOP VARIABLE TRIAL 12MM
• 00643169241763: TRIAL 2570013 LOOP VARIABLE TRIAL 13MM
• 00643169241756: TRIAL 2570014 LOOP VARIABLE TRIAL 14MM
• 00643169241732: TRIAL 2570006 IMPACTOR TRIAL
• 00643169241725: ADPTOR 2570021 LOOP SLAP HAMMER ADAPTOR
• 00643169241718: CAP 2570020 LOOP INSERTER IMPACTOR CAP
• 00643169241688: TRIAL 2570007 LOOP VARIABLE TRIAL 7MM