Home GUDID 00851096008018 Elitone
Primary DI 00851096008018
Brand Elitone
Company Elidah, Inc.
Model EK-1006
Device description Muscle stimulator for the treatment of stress urinary incontinence
Published 2019-04-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true Product Codes# Code, Name table Code Name QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QAJ Cutaneous Electrode Stimulator For Urinary Incontinence Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851096008018 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851096008018 00851096008018 851096008018 0851096008018
GMDN Terms# Term, Definition table Term Definition Perineal orifice incontinence-control electrical stimulation system electrode A device used in a nonimplantable incontinence-control electrical stimulation system for the treatment of urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor, inducing Kegel-like contractions. It is a probe-like lead with a plug at the distal end where the electrodes, typically having both a negative and positive terminal, are situated; it may be inserted into the anus and/or the vagina. The proximal end has a connector to the generator. This is a reusable device.
Regulatory Flags# DUNS number 079300140 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00851096008049 Elitone for Men Elidah, Inc. QAJ 2026-04-10 00851096008155 Elitone for Men Elidah, Inc. QAJ 2026-04-10 00851096008162 Elitone for Men Elidah, Inc. QAJ 2026-04-10 00851096008131 Elitone Elidah, Inc. QAJ 2026-02-18 00851096008148 Elitone URGE Elidah, Inc. QAJ 2026-02-18 00851096008179 Elitone Elidah, Inc. QAJ 2026-02-18 00851096008186 Elitone URGE Elidah, Inc. QAJ 2026-02-18 00851096008056 Elitone Elidah, Inc. QAJ 2024-12-19 00851096008117 Elitone URGE Elidah, Inc. QAJ 2024-12-19 00851096008100 ELITONE URGE Elidah, Inc. QAJ 2023-04-13 15391533470500 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470517 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470524 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470531 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470548 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470555 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470562 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470579 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470586 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470913 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470920 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470937 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470944 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470951 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470968 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470975 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533470982 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533471101 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533471118 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11 15391533471125 INNOVO ATLANTIC THERAPEUTICS LIMITED QAJ 2021-05-11