DEVICE: SJM™ (05415067016553)

Device Identifier (DI) Information

SJM™
3599
In Commercial Distribution
3599
ST. JUDE MEDICAL, INC.
05415067016553
GS1

1
149818952 *Terms of Use
External Pulse Generator, 16 channel
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Device Characteristics

MR Unsafe
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?
61472 Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
An electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb).
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 092
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 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Temperature: between -13 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

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

6a4c82a6-6ff1-468b-9471-80e9c2e9f506
August 01, 2023
4
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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