DEVICE: eCoin External Controller Kit (00860007896972)

Device Identifier (DI) Information

eCoin External Controller Kit
1011-5436
In Commercial Distribution
1011-5436
Valencia Technologies Corporation
00860007896972
GS1

1
968538988 *Terms of Use
eCoin External Controller Kit
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P200036 005
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6a04c0d9-e18a-45c8-ae89-35ef549a4c95
May 05, 2023
1
April 27, 2023
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE