DEVICE: Lamitrode® (05414734402064)
Device Identifier (DI) Information
Lamitrode®
3243
Not in Commercial Distribution
3243
ADVANCED NEUROMODULATION SYSTEMS, INC.
3243
Not in Commercial Distribution
3243
ADVANCED NEUROMODULATION SYSTEMS, INC.
S-4 Lead Kit, 30cm 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.
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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 | 013 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 30 Centimeter |
Device Record Status
73402690-5291-4728-8639-12d181c09b8d
August 15, 2023
6
October 22, 2014
August 15, 2023
6
October 22, 2014
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