DEVICE: NA (05414734400794)

Device Identifier (DI) Information

NA
Communication Wand
In Commercial Distribution
1232
ADVANCED NEUROMODULATION SYSTEMS, INC.
05414734400794
GS1

1
021675699 *Terms of Use
Communication Wand
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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. 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 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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

8d0dc37e-de13-48b2-9833-664f2f4d3e00
January 09, 2023
4
October 21, 2014
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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
No
Yes
No
No CLOSE

Customer Contact

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