DEVICE: InTone®MV (00851508007011)

Device Identifier (DI) Information

InTone®MV
5000000A1
In Commercial Distribution
5000000A1
INCONTROL MEDICAL, LLC
00851508007011
GS1

1
052247990 *Terms of Use
InToneMV
CLOSE

Device Characteristics

MR Unsafe
No
Yes
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?
36050 Perineal orifice incontinence-control electrical stimulation system probe, reusable
An invasive electrical conductor which is a component of a perineal orifice incontinence-control electrical stimulator intended for the treatment of urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor. It connects to an external pulse generator (not included) and is in the form of a cylinder-like probe with surface electrodes for insertion into the vagina and/or anus whereby therapy involves induction of Kegel-like contractions. It is intended for use in both the home (self-treatment) and healthcare facility. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KPI STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K134020 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 54 Degrees Celsius
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 65 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 51.4 Inch
CLOSE

Device Record Status

ad05b665-7316-45da-a2a3-613514a85412
June 02, 2023
6
October 03, 2016
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(262)373-0422
info@incontrolmedical.com
CLOSE