AccessGUDID - DEVICE: External Remote Controller (00856719002220)

GUDID

Device Identifier (DI) Information

Brand Name: External Remote Controller
Version or Model: P003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EAD-P1-020
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00856719002220
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 FREEDOM residual limb lengthening 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 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.	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
Handling Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 3b217011-f8d8-436c-b609-c99fb9a93754
Public Version Date: September 09, 2020
Public Version Number: 5
DI Record Publish Date: October 15, 2015