AccessGUDID - DEVICE: External Remote Controller (00812258022839)

GUDID

Device Identifier (DI) Information

Brand Name: External Remote Controller
Version or Model: ERC2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EAD-M1-000
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00812258022839
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837845234 *Terms of Use

Device Description: External remote controller - for use with the MAGEC spinal bracing and distraction system

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
PGN	Growing Rod System- Magnetic Actuation

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
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: tool/instrument

Device Record Status

Public Device Record Key: 5c998ff8-ab82-46fa-abe4-f06a025e3320
Public Version Date: May 28, 2025
Public Version Number: 7
DI Record Publish Date: October 15, 2015