Magec External Remote Controller

Basic Information

• Brand Name: Magec External Remote Controller
• Primary DI: 00887517723901
• Version / Model: ERC 2
• Catalog Number: EAD-M1-000
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Labeler DUNS: 837845234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-20
• Public Version: 1
• Public Version Date: 2021-10-28
• Public Version Status: New
• Public Device Record Key: 68819c2c-0c45-44d5-a918-0fe704ac1394

Device Description

MAGEC ERC2, Shipping Pkg US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43538	Distraction plate/rod adjustment remote control	A portable, hand-held, electrically-powered device intended to be used to noninvasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail) to achieve the correct length; it may be used intraoperatively to test the functionality of the plate/rod. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517723901	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]