DEVICE: SJM™ (05415067017857)

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Device Identifier (DI) Information

SJM™
1124
1124
ST. JUDE MEDICAL, INC.
05415067017857
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Catheter stylet A metal wire or flexible rod, typically with a plastic knob at the proximal end, that is inserted into the lumen of a catheter or cannula to provide internal reinforcement to increase the stiffness enough to facilitate manipulation and introduction into the body for various procedures. It is available in various lengths, diameters, and degrees of rigidity. Some types can include small passive magnets that generate a magnetic field which is detectable by an external catheter stylet magnet detector. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Special Storage Condition, Specify: DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
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Clinically Relevant Size

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Size Type Text
Length: 60 Centimeter
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Device Status

In Commercial Distribution
March 17, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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