FDA.reportPublic FDA data

Lighted Suction

Primary DI
00859911004733
Brand
Lighted Suction
Company
Bionix, LLC
Model
2625
Catalog number
2625
Device description
Lighted Suction Handle
Published
2021-12-16
Public version status
Update
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
JZFTUBE, EAR SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859911004733PrimaryGS10
10859911004730Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004733008599110047338599110047330859911004733
1085991100473010859911004730

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal suction handleA noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula (not included) for suction/removal (aspiration) of debris from the ear canal during an ear/nose/throat (ENT) procedure; it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which may incorporate a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
25
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911004948OtoClear® 60cc Luer Lock Syringe Kit723572352022-01-07
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

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Primary DI, Brand, Company table
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04054462902101evonosevonos GmbH & Co. KGJZF2026-08-21
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04054462904419evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904426evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
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04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904525evonosevonos GmbH & Co. KGJZF2026-08-21