DEVICE: eCoin External Controller Kit (00860007896972)
Device Identifier (DI) Information
eCoin External Controller Kit
1011-5436
In Commercial Distribution
1011-5436
Valencia Technologies Corporation
1011-5436
In Commercial Distribution
1011-5436
Valencia Technologies Corporation
eCoin External Controller Kit
Device Characteristics
MR Unsafe | |
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? |
---|---|---|---|---|
64780 | Tibial nerve implantable incontinence-control electrical stimulation system |
An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the sacral plexus via tibial nerve stimulation. It consists of an electrode implanted in the vicinity of the tibial nerve, an external transcutaneous pulse generator attached to the leg, and an external programmer/transmitter that communicates with the pulse generator.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QPT | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P200036 | 005 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6a04c0d9-e18a-45c8-ae89-35ef549a4c95
May 05, 2023
1
April 27, 2023
May 05, 2023
1
April 27, 2023
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
[?]
No Customer Contact currently defined