DEVICE: Eon Mini™ (05414734402613)
Device Identifier (DI) Information
Eon Mini™
3719
Not in Commercial Distribution
3719
ADVANCED NEUROMODULATION SYSTEMS, INC.
3719
Not in Commercial Distribution
3719
ADVANCED NEUROMODULATION SYSTEMS, INC.
Charging System Charger
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
17115 | Noninvasive device battery charger |
An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.
|
Active | false |
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 | 023 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
eb2770fc-5a62-4716-8a81-890ed579626b
January 09, 2023
6
October 22, 2014
January 09, 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