MAGEC

GUDID 00887517834027

MAGEC 2 Rod, 5.0mm 70mm Standard

Nuvasive, Inc.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00887517834027
• NIH Device Record Key: bf712f9f-ee54-49cd-8710-8a8a833f74ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGEC
• Version Model Number: MC2-5070S
• Company DUNS: 053950783
• Company Name: Nuvasive, 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: 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: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517834027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171791

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-09

On-Brand Devices [MAGEC]

• 00887517834041: MAGEC 2 Rod, 5.0mm 90mm Standard
• 00887517834034: MAGEC 2 Rod, 5.0mm 90mm Offset
• 00887517834027: MAGEC 2 Rod, 5.0mm 70mm Standard
• 00887517834010: MAGEC 2 Rod, 5.0mm 70mm Offset
• 00887517833921: MAGEC 5.5mm Rod Set
• 00887517833914: MAGEC 5.0mm Rod Set
• 00887517833907: MAGEC 4.5mm Rod Set
• 00887517696748: MAGEC ERC1
• 00887517695536: MAGEC ERC2