DEVICE: SJM™ (05414734400763)

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Device Identifier (DI) Information

SJM™
1210
1210
ADVANCED NEUROMODULATION SYSTEMS, INC.
05414734400763
GS1
1
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Implantable stimulator control magnet A hand-operated, non-sterile, magnetic device designed to be used by a patient to switch an implanted stimulator (e.g., a neurostimulator that can be controlled by a strong external magnetic force) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implanted stimulator and turned as prescribed by the manufacturer to affect the stimulator. This is a reusable device.
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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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Sterilization

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

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Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 23, 2014

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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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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