External Remote Controller EAD-P3-010

GUDID 00887517001344

External remote controller - for use with the PRECICE intramedullary limb lengthening system

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Distraction plate/rod controller
Primary Device ID00887517001344
NIH Device Record Key840dc9c3-af42-494a-8ee9-0a39a6cbd4cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameExternal Remote Controller
Version Model NumberERC-3P
Catalog NumberEAD-P3-010
Company DUNS837845234
Company NameNUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com

Device Dimensions

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Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517001344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2017-12-21

On-Brand Devices [External Remote Controller]

00812258022877External remote controller - for use with the PRECICE intramedullary limb lengthening system
00812258022839External remote controller - for use with the MAGEC spinal bracing and distraction system
00887517001344External remote controller - for use with the PRECICE intramedullary limb lengthening system
00856719002220External remote controller - for use with the FREEDOM residual limb lengthening system
00856719002107External remote controller - for use with the MAGEC spinal bracing and distraction system
00856719002039External remote controller - for use with the PRECICE intramedullary limb lengthening system
00887517014979ERC-for use with PRECICE System

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