DEVICE: Quattrode™ (05414734406048)

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Device Identifier (DI) Information

Quattrode™
3146
3146
ST. JUDE MEDICAL, INC.
05414734406048
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
Analgesic spinal cord electrical stimulation system An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.
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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 Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Special Storage Condition, Specify: DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius
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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 11, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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