FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040168561
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703275
Catalog number
5703275
Device description
Multi Enzyme Detergent - Liquid - Gallon
Published
2023-05-19
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

Product Codes#

Code, Name table
CodeName
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040168561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040168561003040401685613040401685610304040168561

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
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
true
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970057578248Disposable Cleaning BrushJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNL2026-05-22
00724995233327DuoswiftUS EndoscopyMNL2026-03-12
00817169024989Pristine by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMNL2026-03-05
10850075039002Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039033Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039057Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039071Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039095Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039118Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039125Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039156Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039194Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10850075039217Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860002853106Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
00860002853192Venturi MicroDryerGI SCIENTIFIC LLCMNL2026-02-10
10860007020909Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860007020947Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
20860007020968Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
00860007020971Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039149Venturi DryGI SCIENTIFIC LLCMNL2026-02-09
00190776415686MillenniumAvalign Technologies, Inc.MNL2026-02-04
00198506087370ELMED INCORPORATEDELMED INCORPORATEDMNL2026-01-07
G4533352003290PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
G4533353003310PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
00850067560227LaproClearSurgical Principals, IncMNL2025-12-11
00816185001165AquaBrush SystemTorvan Medical IncMNL2025-12-08
16936603228934Single Use Angulation Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
00198506018268ELMED INCORPORATEDELMED INCORPORATEDMNL2025-09-05
00198506084775ELMED INCORPORATEDELMED INCORPORATEDMNL2025-08-26