DEVICE: SJM™ (05414734400176)

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Device Identifier (DI) Information

SJM™
1120
1120
ADVANCED NEUROMODULATION SYSTEMS, INC.
05414734400176
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
Tendon/ligament tunneller A long, hand-held, manual surgical instrument designed to tunnel an artificial passageway along ligament and/or tendon tissue to create a connecting channel. It can have a variety of designs: 1) a long, round, stiff rod that tapers to a rounded point at the distal tip with a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue; or 2) a ring-handled instrument with long, slightly curved arms that join at a pivot point near the distal end, terminating in short grasping arms. It will typically be made of high-grade stainless steel. This is a reusable 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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
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Clinically Relevant Size

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Size Type Text
Length: 20 Inch
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Device Status

In Commercial Distribution
October 23, 2014

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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
15414734400173 5 05414734400176 In Commercial Distribution
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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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