DEVICE: SJM™ (05415067016560)

Device Identifier (DI) Information

SJM™
3032
In Commercial Distribution
3032
ST. JUDE MEDICAL, INC.
05415067016560
GS1

1
149818952 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Personal device holder, reusable A patient-worn device intended to be used to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) during ambulation or sleep; it is not designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder). It may be designed as a bag, pouch, shoulder strap, belt, strap, clothing, or other configuration. This is a reusable device.
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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 [?]
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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -13 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
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Clinically Relevant Size

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

f45d7fcc-5eeb-411c-b68d-5924e52b2b0c
September 24, 2018
3
July 29, 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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