AccessGUDID - DEVICE: Magec External Remote Controller (00887517730657)

GUDID

Device Identifier (DI) Information

Brand Name: Magec External Remote Controller
Version or Model: ERC 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ERC 2
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00887517730657
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837845234 *Terms of Use

Device Description: MAGEC ERC 2

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43538	Distraction implant adjustment remote control	A portable, hand-held, electrically-powered device intended to noninvasively and remotely adjust the length of a previously-implanted extramedullary distraction plate and/or intramedullary distraction nail to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rod to correct spinal deformities; it may be used intraoperatively to test the functionality of the implantable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed11f933-882b-4b14-9084-ffd6d41773a2
Public Version Date: May 28, 2025
Public Version Number: 3
DI Record Publish Date: October 20, 2021