DEVICE: Axium™ (05415067025524)
Device Identifier (DI) Information
Axium™
MN10350-90A
Not in Commercial Distribution
MN10350-90A
SPINAL MODULATION, INC.
MN10350-90A
Not in Commercial Distribution
MN10350-90A
SPINAL MODULATION, INC.
90cm SlimTip Trial Lead Kit
Device Characteristics
MR Unsafe | |
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 |
---|---|
PMP | Dorsal root ganglion stimulator for pain relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P150004 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged. |
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between -10 and 50 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 90 Centimeter |
Device Record Status
52cdad2f-87fa-46e8-b2cf-b88700727be9
August 15, 2023
4
March 29, 2016
August 15, 2023
4
March 29, 2016
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