FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040142398
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702441
Catalog number
5702441
Device description
Single Use Aerosol Evacuator
Published
2021-03-01
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
true

Related Records

Product Codes

CodeName
DYNMouthpiece, saliva ejector

Product Code Classifications

CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040142398PackageGS111In Commercial Distribution
10304040142391PrimaryGS10
00304040142394Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404014239820304040142398
1030404014239110304040142391
00304040142394003040401423943040401423940304040142394

GMDN Terms

TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
50
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
false
Expiration date on label
false
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 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 DIBrandCompanyProduct codePublished
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample PZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
07615208584981Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208584998Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208543506Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.DYN2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.DYN2025-06-17
00840161310668Pink Petal™ - Saliva Ejector Holder - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2025-01-09
50732224005008Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224004988Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
TQ26SE2555020Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
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TQ26SE2555520Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555600Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555720Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555820Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555920Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2556020Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2556120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
00304040186527Henry ScheinHENRY SCHEIN, INC.DYN2024-09-19
00304040186534Henry ScheinHENRY SCHEIN, INC.DYN2024-09-19