Elitone

GUDID 00851096008001

Elitone GelPads are transcutaneous electrodes to be used with the Elitone Device.

ELIDAH, INC.

Perineal orifice incontinence-control electrical stimulation system electrode
Primary Device ID00851096008001
NIH Device Record Keya72b6f76-1787-4592-92eb-d5dd9aeab32e
Commercial Distribution Discontinuation2019-04-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameElitone
Version Model NumberEE-1002
Company DUNS079300140
Company NameELIDAH, INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851096008001 [Primary]
GS100851096008025 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QAJCutaneous Electrode Stimulator For Urinary Incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-09
Device Publish Date2019-04-01

On-Brand Devices [Elitone]

00851096008018Muscle stimulator for the treatment of stress urinary incontinence
00851096008001Elitone GelPads are transcutaneous electrodes to be used with the Elitone Device.
00851096008025ELITONE GelPads are transcutaneous electrodes to be used with the ELITONE Device.

Trademark Results [Elitone]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELITONE
ELITONE
87363231 5313764 Live/Registered
Elidah, Inc.
2017-03-08

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