DEVICE: Prodigy™ (05415067021113)

Device Identifier (DI) Information

Prodigy™
3856
In Commercial Distribution
3856
ST. JUDE MEDICAL, INC.
05415067021113
GS1

1
149818952 *Terms of Use
Patient Programmer
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Device Characteristics

MR Unsafe
No
No
No
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
Multi-purpose electrical stimulation system programmer An external, portable, battery-powered device intended to change, noninvasively (i.e., wirelessly) the operating parameters (programs) of multiple types of implanted electrical stimulation system pulse generators (non-dedicated). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.
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FDA Product Code

[?]
Product Code Product Code Name
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

1f194c17-959b-415f-b9e6-29a35e5a8603
March 29, 2018
2
December 01, 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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