DEVICE: Lamitrode™ (05414734406253)
Device Identifier (DI) Information
Lamitrode™
3246
In Commercial Distribution
3246
ST. JUDE MEDICAL, INC.
3246
In Commercial Distribution
3246
ST. JUDE MEDICAL, INC.
S-4 Lead Kit, 60cm Length
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? |
---|---|---|---|---|
62423 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection |
An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.
|
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 | 013 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 60 Centimeter |
Device Record Status
965524c8-00d2-4fa2-ac83-4c3e583f774a
August 01, 2023
4
March 11, 2015
August 01, 2023
4
March 11, 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