DEVICE: St. Jude Medical Infinity™ (05415067020659)

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Device Identifier (DI) Information

St. Jude Medical Infinity™
DBS System
6179
ST. JUDE MEDICAL, INC.
05415067020659
GS1
1
8CH Directional Lead, 30 cm, 1.5
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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
Deep brain electrical stimulation system An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.
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FDA Product Code

[?]
Product Code Product Code Name
MHY STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Special Storage Condition, Specify: Store components and their packaging where they will not come in contact with liquids of any kind.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 14, 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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

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