DEVICE: External Remote Controller (00887517001344)
Device Identifier (DI) Information
External Remote Controller
ERC 3P
In Commercial Distribution
EAD-P3-010
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 3P
In Commercial Distribution
EAD-P3-010
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
PRECICE ERC 3P Shipping Pkg US
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 [?] |
---|---|
K170169 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage 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
840dc9c3-af42-494a-8ee9-0a39a6cbd4cf
May 28, 2025
9
December 21, 2017
May 28, 2025
9
December 21, 2017
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 |
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