MAGEC® Manual Distractor MMD-001-U

GUDID 00812258026882

Manual distractor - for use with the MAGEC® Spinal Bracing and Distraction System

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00812258026882
• NIH Device Record Key: 518a2ca0-8d3a-41a4-aeef-9b848f7e1bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGEC® Manual Distractor
• Version Model Number: MMD-001-U
• Catalog Number: MMD-001-U
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812258026882 [Primary]

FDA Product Code

• PGN: Growing Rod System- Magnetic Actuation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-25
• Device Publish Date: 2015-12-23

On-Brand Devices [MAGEC® Manual Distractor]

• 00812258026882: Manual distractor - for use with the MAGEC® Spinal Bracing and Distraction System
• 00812258022723: Manual distractor - for use with the MAGEC® Spinal Bracing and Distraction System
• 00812258022242: Manual distractor - for use with the MAGEC® Spinal Bracing and Distraction System