DEVICE: SJM™ (05415067017826)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64578 | Central nervous system electrical stimulation system lead stylet |
A wire intended to be percutaneously inserted into the brain and/or epidural space to aid in the percutaneous placement of an implantable central nervous system (CNS) electrical stimulation system lead. It is manipulated proximally with the distal working end typically comprised of thin metal wire. This is a single-use device.
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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 | 014 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Special Storage Condition, Specify: DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 90 Centimeter |
Device Record Status
d5c36e0a-3df3-45fb-b513-416aab46ae23
August 01, 2023
4
March 17, 2015
August 01, 2023
4
March 17, 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