FDA.reportPublic FDA data

Ear Wax Removal Kit 12 Ct. Case

Primary DI
10714646000672
Brand
Ear Wax Removal Kit 12 Ct. Case
Company
Bionix, LLC
Model
704
Catalog number
704
Device description
Ear Wax Removal Kit 12 Ct. Case
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGQEar irrigation kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGQEar Irrigation KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10714646000672PrimaryGS10
00714646000675Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071464600067210714646000672
00714646000675007146460006757146460006750714646000675

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, single-useA 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 manual syringe and other accessory items. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
12
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
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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
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00714646001108Microsuction Replacement Pack2651LS-026512025-07-08
00859911004795Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16971919460500Medi GradeNingbo Albert Novosino Co.,Ltd.OGQ2025-11-20
00714646000675Ear Wax Removal KitBionix, LLCOGQ2024-07-11
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00860007911460Cleanse RightBlue Echo Care LLCOGQ2024-06-20
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00653160022766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
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