DEVICE: Axium™ (05415067025593)
Device Identifier (DI) Information
Axium™
MN10700
In Commercial Distribution
MN10700
ST. JUDE MEDICAL, INC.
MN10700
In Commercial Distribution
MN10700
ST. JUDE MEDICAL, INC.
Clinical Programmer Kit
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? |
---|---|---|---|---|
61588 | Implantable spinal cord electrical stimulation system programmer |
A battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PMP | Dorsal root ganglion stimulator for pain relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P150004 | 000 |
P150004 | 005 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Handling Environment Humidity: between 0 and 93 Percent (%) Relative Humidity |
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Handling Environment Temperature: between -10 and 50 Degrees Celsius |
Special Storage Condition, Specify: Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
96d989b1-9f05-4f6f-934d-4e492505f520
July 06, 2018
3
March 29, 2016
July 06, 2018
3
March 29, 2016
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