DEVICE: NA (05415067016140)
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? |
---|---|---|---|---|
48054 | Neural-tissue electrical stimulation lead adaptor |
A sterile implantable device intended to provide a functional and modified connection between existing neurostimulation leads and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination.
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Active | true |
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 | 094 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Special Storage Condition, Specify: KEEP DRY |
Clinically Relevant Size
[?]Size Type Text |
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Length: 60 Centimeter |
Device Record Status
a7384908-ce6f-4600-bef4-a64e2a7a3c61
January 09, 2023
4
April 22, 2015
January 09, 2023
4
April 22, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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