DEVICE: SJM™ (05415067023803)

Device Identifier (DI) Information

SJM™
3870
Not in Commercial Distribution
3870
ADVANCED NEUROMODULATION SYSTEMS, INC.
05415067023803
GS1
March 28, 2018
1
021675699 *Terms of Use
Clinician Programmer App
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Device Characteristics

Labeling does not contain MRI Safety Information
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

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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

caf04993-84ae-4b79-a20f-07a1d6efb0ec
April 23, 2018
4
July 30, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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
No
No
No CLOSE

Customer Contact

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