FDA.reportPublic FDA data

OtoClear Tip Sample

Primary DI
00714646000576
Brand
OtoClear Tip Sample
Company
Bionix, LLC
Model
27230
Catalog number
27230
Device description
OtoClear Tip Sample
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
KCPSYRINGE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646000576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000576007146460005767146460005760714646000576

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation tipA small, rigid, funnel-shaped device intended to provide a conduit for irrigation of the ear canal to flush out cerumen (ear wax) in conjunction with a flushing device (e.g., pump, spray bottle, syringe) [not included] during an ear/nose/throat (ENT) procedure; it is not intended for examination, suction or instrument insertion. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
1
Premarket exempt
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
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.KCP2025-12-15
16971919460494Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-17
16971919460432Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-11
00661392001855LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392010437LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392012486LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392027701LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00194613021535MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00194613112639MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00757770410651Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435401Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435999Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770436620Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770457588Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00661392010444LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392010451LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392010802LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392013414LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392045392LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010441LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010458LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010809LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392013411LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392045399LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00370275092025FS Dispenser, StainlessForward Science Technologies LLCKCP2024-10-14
EDET031591mixing cannulas optima lilac 50 pcs.DETAX GmbHKCP2024-08-28
EDET031601mixing cannulas optima lilac 100 pcs.DETAX GmbHKCP2024-08-28
EDET041941mixing cannulas Automix 2 T-Mixer yellow 25 pcsDETAX GmbHKCP2024-08-28
00840183511951BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00840183511968BR Surgical, LLCBR Surgical, LLCKCP2024-06-10