DEVICE: NA (05414734400794)
Device Identifier (DI) Information
NA
Communication Wand
In Commercial Distribution
1232
ADVANCED NEUROMODULATION SYSTEMS, INC.
Communication Wand
In Commercial Distribution
1232
ADVANCED NEUROMODULATION SYSTEMS, INC.
Communication Wand
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
61393 | Multiple active implantable device programmer |
An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P010032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8d0dc37e-de13-48b2-9833-664f2f4d3e00
January 09, 2023
4
October 21, 2014
January 09, 2023
4
October 21, 2014
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
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com