DEVICE: Axium™ (05415067025609)
Device Identifier (DI) Information
Axium™
MN12150
In Commercial Distribution
MN12150
SPINAL MODULATION, INC.
MN12150
In Commercial Distribution
MN12150
SPINAL MODULATION, INC.
22cm Small Curve Delivery Sheath 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? |
---|---|---|---|---|
44063 | Neurosurgical procedure kit, non-medicated, single-use |
A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.
|
Active | false |
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 |
---|
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Handling 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 |
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged. |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 22 Centimeter |
Device Record Status
258f6659-6a6b-4a47-98be-5594db0c05fe
July 06, 2018
3
March 29, 2016
July 06, 2018
3
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