FDA.reportPublic FDA data

Ear canal irrigation kit, reusable

Definition
A collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.
GUDID devices
26
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00714646000729OtoClear SprayWash System, Single UseBionix, LLC72912024-07-11
0071464600074327245Bionix, LLC272452024-07-11
0071464600075027275Bionix, LLC272752024-07-11
00859911004795Tabletop Waterpik Adapter WandsBionix, LLC272102024-07-11
00859911004801Portable WaterPik Adapter WandsBionix, LLC272152024-07-11
10304040127855Henry ScheinHENRY SCHEIN, INC.57018842021-04-28
20304040127869Henry ScheinHENRY SCHEIN, INC.57018832021-04-23
M752A10011Stradis Medical, LLCSTRADIS MEDICAL LLCA-10012019-08-23
16971919462535Medi GradeNingbo Albert Novosino Co.,Ltd.60ml2025-12-29
16971919460500Medi GradeNingbo Albert Novosino Co.,Ltd.20ML2025-11-20
00714646000736OtoClear SprayWash System, Single Use SampleBionix, LLC272912024-07-11
10859911004792Tabletop Waterpik Adapter WandsBionix, LLC272102024-07-11
00691835141008caring millBlue Echo Care LLCCM-EE-VOIV-PVOI2024-06-20
00810025926854caring millBlue Echo Care LLCCM-PP-VOIV-PVOI2024-06-20
00860007911446Cleanse RightBlue Echo Care LLCCR-EARSPRLKIT-12024-06-20
00860007911453Cleanse RightBlue Echo Care LLCCR-EARKIT-12024-06-20
00860007911460Cleanse RightBlue Echo Care LLCCR-ELTRNEAR-12024-06-20
00714646001177SprayWash Adapter WandBionix, LLC272212023-08-09
00859911004818OtoClear SprayWash Adapter WandBionix, LLC272192023-07-21
00859911004900OtoClear AquaBot Adapter WandBionix, LLC272172023-07-21
00714646000767OtoClear® Spray Wash, SampleBionix, LLC272952022-01-07
00859911004290OtoClear® Spray Wash KitBionix, LLC72952022-01-07
00859911004887OtoClear® Aquabot® KitBionix, LLC72702022-01-07
00859911004894OtoClear® Aquabot® KitBionix, LLC72752022-01-07
00304040127858Henry ScheinHENRY SCHEIN, INC.57018842021-04-28
30304040127866Henry ScheinHENRY SCHEIN, INC.57018832021-04-23