DEVICE: Rapid Programmer™ (05415067016492)

Device Identifier (DI) Information

Rapid Programmer™
3834
In Commercial Distribution
3834
ST. JUDE MEDICAL, INC.
05415067016492
GS1

1
149818952 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61393 Multiple active implantable device programmer
An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. 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.
Active false
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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 [?]
P010032 053
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 70 and 101 KiloPascal
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 101 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between -10 and 55 Degrees Celsius
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Clinically Relevant Size

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

e7d2bfaa-aaea-42b9-a3d8-d5308234bf3d
January 09, 2023
5
March 11, 2015
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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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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