DEVICE: External Remote Controller (00856719002039)

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Device Identifier (DI) Information

External Remote Controller
P003
EAD-P1-010
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
00856719002039
GS1
1
External remote controller - for use with the PRECICE intramedullary limb lengthening system
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
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.
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FDA Product Code

[?]
Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: tool/instrument
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Device Status

In Commercial Distribution
October 15, 2015

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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
855-435-5477
csdepartment@ellipse-tech.com
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