DEVICE: SJM™ (05415067016553)
Device Identifier (DI) Information
SJM™
3599
In Commercial Distribution
3599
ST. JUDE MEDICAL, INC.
3599
In Commercial Distribution
3599
ST. JUDE MEDICAL, INC.
External Pulse Generator, 16 channel
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P010032 | 092 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6a4c82a6-6ff1-468b-9471-80e9c2e9f506
August 01, 2023
4
July 29, 2015
August 01, 2023
4
July 29, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com