DEVICE: Axium™ (05415067025593)

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Device Identifier (DI) Information

Axium™
MN10700
MN10700
ST. JUDE MEDICAL, INC.
05415067025593
GS1
1
Clinical Programmer Kit
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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
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.
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FDA Product Code

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Product Code Product Code Name
PMP Dorsal root ganglion stimulator for pain relief
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
March 29, 2016

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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