AccessGUDID - DEVICE: External Remote Controller (00856719002039)

GUDID

Device Identifier (DI) Information

Brand Name: External Remote Controller
Version or Model: P003
Catalog Number: EAD-P1-010
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00856719002039
Issuing Agency: GS1
Device Count: 1

Device Description: External remote controller - for use with the PRECICE intramedullary 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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Magnetically-adjustable orthopaedic implant actuator	A portable, hand-held, mains electricity (AC-powered) device intended to be used to non-invasively adjust the length of an orthopaedic implant of the type designed to be influenced by an external magnetic field. It typically consists of two electrically-rotated magnets positioned on either side of an implant locating window, and an operator control panel with settings and display. It is intended to be placed directly over the implant, which can be extended or retracted when the magnets run. It is intended for spinal distraction rods to correct spinal deformities, or intramedullary distraction rods for long bone fractures and limb length discrepancies.

GMDN Preferred Term Name

GMDN Definition

Magnetically-adjustable orthopaedic implant actuator

A portable, hand-held, mains electricity (AC-powered) device intended to be used to non-invasively adjust the length of an orthopaedic implant of the type designed to be influenced by an external magnetic field. It typically consists of two electrically-rotated magnets positioned on either side of an implant locating window, and an operator control panel with settings and display. It is intended to be placed directly over the implant, which can be extended or retracted when the magnets run. It is intended for spinal distraction rods to correct spinal deformities, or intramedullary distraction rods for long bone fractures and limb length discrepancies.

FDA Product Code

[?]

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

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

Clinically Relevant Size

[?]

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

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: October 15, 2015
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: External Remote Controller (00856719002039)