DEVICE: Axium™ (05415067025609)

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Device Identifier (DI) Information

Axium™
MN12150
MN12150
SPINAL MODULATION, INC.
05415067025609
GS1
1
22cm Small Curve Delivery Sheath Kit
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Device Characteristics

MR Unsafe
No
No
Yes
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
Neurosurgical procedure kit, non-medicated, single-use A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.
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FDA Product Code

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

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

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged.
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Clinically Relevant Size

[?]
Size Type Text
Length: 22 Centimeter
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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

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

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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