DEVICE: External Remote Controller (00856719002220)

Device Identifier (DI) Information

External Remote Controller
P003
In Commercial Distribution
EAD-P1-020
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
00856719002220
GS1

1
837845234 *Terms of Use
External remote controller - for use with the FREEDOM residual 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
Long bone adjustable nail controller 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 remotely-adjusted. It is intended to be used with 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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

3b217011-f8d8-436c-b609-c99fb9a93754
March 29, 2018
2
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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