FDA.reportPublic FDA data

OtoClear Ear Irrigation System Wands

Primary DI
10714646000474
Brand
OtoClear Ear Irrigation System Wands
Company
Bionix, LLC
Model
27220
Catalog number
27220
Device description
Ear Irrigation System Adapter Wands, 3 ct
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00714646000477PrimaryGS10
10714646000474Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000477007146460004777146460004770714646000477
1071464600047410714646000474

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal lavage systemA device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
3
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911004184Bionix Development Corporation370037002017-01-28
00859911004498Safe Ear Curette™ Variety Kit577757772021-12-10
00859911004429Green MicroLoop®122212222021-12-10
00859911004436Orange ControLoop®299929992021-12-10
00859911004443Red AngleLoop®344434442021-12-10
00859911004450Purple VersaLoop®411141112021-12-10
00859911004467Blue InfantScoop®488848882021-12-10
00859911004474Yellow CeraSpoon®633363332021-12-10
00859911004481White FlexLoop®955595552021-12-10
00859911004528Lighted AngleLoop®221022102021-12-10
00859911004535Lighted MicroLoop®222022202021-12-10
00859911004542Lighted WaveCurette™223022302021-12-10
00859911004559Lighted FlexLoop®224022402021-12-10
00859911004566Lighted Ear Curette™ Variety Pack224522452021-12-10
00859911004573Lighted CeraSpoon®225022502021-12-10
00859911004580Lighted InfantScoop®226022602021-12-10
00859911004597Lighted VersaLoop®227022702021-12-10
00859911004603Lighted CeraPik™228022802021-12-10
00859911004702Lighted Forceps for Foreign Body Removal275027502021-12-10
00859911004726Lighted Placement Tool285028502022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00714646000729OtoClear SprayWash System, Single UseBionix, LLCLRD2024-07-11
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
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
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