FDA.reportPublic FDA data

Microsuction Replacement Pack

Primary DI
00714646001108
Brand
Microsuction Replacement Pack
Company
Bionix, LLC
Model
2651
Catalog number
LS-02651
Device description
Microsuction Replacement Pack
Published
2025-07-08
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
FZZMARKER, SKIN
JZFTUBE, EAR SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646001009PrimaryGS10
00714646001108Unit of UseGS10
10714646001105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646001009007146460010097146460010090714646001009
00714646001108007146460011087146460011080714646001108
1071464600110510714646001105

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking stickerA hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To maximize shelf-life, keep Opti-Tatt in the freezer between use
Storage Environment Temperature0 Degrees Fahrenheit40 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
25
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
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
00190776423827MillenniumAvalign Technologies, Inc.JZF2026-08-26
04054462901975evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901982evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901999evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902002evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902019evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902026evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902033evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902040evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902057evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902064evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902088evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902095evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902101evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902118evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902125evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902132evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902149evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904396evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904402evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904419evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904426evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904440evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904457evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904471evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904525evonosevonos GmbH & Co. KGJZF2026-08-21