DEVICE: Rapid Programmer™ (05415067016492)
Device Identifier (DI) Information
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P010032 | 053 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e7d2bfaa-aaea-42b9-a3d8-d5308234bf3d
January 09, 2023
5
March 11, 2015
January 09, 2023
5
March 11, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com