DEVICE: External Remote Controller (00856719002039)
Device Identifier (DI) Information
External Remote Controller
P003
In Commercial Distribution
P003
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
P003
In Commercial Distribution
P003
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
External Remote Controller
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
43538 | Distraction implant adjustment remote control |
A portable, hand-held, electrically-powered device intended to noninvasively and remotely adjust the length of a previously-implanted extramedullary distraction plate and/or intramedullary distraction nail to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rod to correct spinal deformities; it may be used intraoperatively to test the functionality of the implantable device.
|
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 |
Sterilization
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 Record Status
5a7a143c-66c8-4ec8-919d-d0bee27080ad
May 28, 2025
8
October 15, 2015
May 28, 2025
8
October 15, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00195377000484 | 1 | 00856719002039 | In Commercial Distribution | Pelican Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-456-2871
info@globusmedical.com
info@globusmedical.com