FDA.reportPublic FDA data

OtoClear SprayWash System, Single Use

Primary DI
00714646000729
Brand
OtoClear SprayWash System, Single Use
Company
Bionix, LLC
Model
7291
Catalog number
7291
Device description
OtoClear Spray Wash System, Single Use
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRDAPPLICATOR, ENT DRUG

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRDApplicator, Ent DrugEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646000729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000729007146460007297146460007290714646000729

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, reusableA 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007146460007432724527245272452024-07-11
007146460007502727527275272752024-07-11
0071464600098927247SP-27247272472022-10-27
00714646001535Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
10714646001532Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
00714646001627Lighted Magnetic Foreign Body Removal Tool352135212026-03-03
00714646001528Lighted Articulating Ear Curettes - Refill251225122025-11-22
00714646001559Rechargeable Light Source360036002025-11-22
00714646001566ClearLook Variety Pack with Rechargeable Light Source364536452025-11-22
00714646001573ClearLook LEC, Sample Pack-Curettes Only23300233002025-11-22
00714646001580ClearLook Variety Pack334533452025-11-22
00714646001597ClearLook CeraSpoon335033502025-11-22
00714646001603ClearLook Variety, 50ct Refill Pack344534452025-11-22
00714646001610ClearLook CeraSpoon, 50ct Refill Pack345034502025-11-22
00859911004160OtoClear Tips720072002017-01-28
00714646001092Lighted Microsuction System2650LS-026502025-07-08
00714646001108Microsuction Replacement Pack2651LS-026512025-07-08
00859911004795Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11
10859911004792Tabletop Waterpik Adapter Wands27210272102024-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0071464600074327245Bionix, LLCLRD2024-07-11
0071464600075027275Bionix, LLCLRD2024-07-11
00859911004795Tabletop Waterpik Adapter WandsBionix, LLCLRD2024-07-11
00859911004801Portable WaterPik Adapter WandsBionix, LLCLRD2024-07-11
00714646000736OtoClear SprayWash System, Single Use SampleBionix, LLCLRD2024-07-11
10859911004792Tabletop Waterpik Adapter WandsBionix, LLCLRD2024-07-11
00714646000675Ear Wax Removal KitBionix, LLCLRD2024-07-11
00714646001177SprayWash Adapter WandBionix, LLCLRD2023-08-09
00714646000477OtoClear Ear Irrigation System WandsBionix, LLCLRD2023-07-21
10714646000474OtoClear Ear Irrigation System WandsBionix, LLCLRD2023-07-21
06936189900746WUSHGUANGDONG OKAY TECHNOLOGY CO.,LTD.LRD2023-03-06
06936189900753WUSHGUANGDONG OKAY TECHNOLOGY CO.,LTD.LRD2023-03-06
00714646000965OtoClear® Ear Irrigation System (220V)Bionix, LLCLRD2022-10-27
00714646000972OtoClear® Ear Irrigation System (220V)Bionix, LLCLRD2022-10-27
0071464600098927247Bionix, LLCLRD2022-10-27
00859911004290OtoClear® Spray Wash KitBionix, LLCLRD2022-01-07
00859911004887OtoClear® Aquabot® KitBionix, LLCLRD2022-01-07
00859911004894OtoClear® Aquabot® KitBionix, LLCLRD2022-01-07
05060180256319EXMOOREXMOOR PLASTICS LIMITEDLRD2018-09-10
05060180251963EXMOOREXMOOR PLASTICS LIMITEDLRD2018-09-10
00859911004146Bionix Development CorporationBionix, LLCLRD2017-01-28
00859911004153Bionix Development CorporationBionix, LLCLRD2017-01-28