FDA.reportPublic FDA data

Henry Schein

Primary DI
H65810080041
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1008004
Catalog number
1008004
Device description
Air Water Syringe
Published
2019-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65810080041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810230800116DCI PartsDCI International, LLCECB2026-06-26
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00810230800147DCI PartsDCI International, LLCECB2026-06-26
00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26
00810230800208DCI PartsDCI International, LLCECB2026-06-26
00810230800215DCI PartsDCI International, LLCECB2026-06-26
00810230800222DCI PartsDCI International, LLCECB2026-06-26
00810230800239DCI PartsDCI International, LLCECB2026-06-26
00810230800246DCI PartsDCI International, LLCECB2026-06-26
00810230800253DCI PartsDCI International, LLCECB2026-06-26
00810230800260DCI PartsDCI International, LLCECB2026-06-26
00810230800277DCI PartsDCI International, LLCECB2026-06-26
00810230800284DCI PartsDCI International, LLCECB2026-06-26
00810230800291DCI PartsDCI International, LLCECB2026-06-26
00810230800307DCI PartsDCI International, LLCECB2026-06-26
00810230800314DCI PartsDCI International, LLCECB2026-06-26
00810230800321DCI PartsDCI International, LLCECB2026-06-26
00810230800338DCI PartsDCI International, LLCECB2026-06-26
00810230800345DCI PartsDCI International, LLCECB2026-06-26
00810230800352DCI PartsDCI International, LLCECB2026-06-26
00810230800369DCI PartsDCI International, LLCECB2026-06-26
00810230800376DCI PartsDCI International, LLCECB2026-06-26
00810230800383DCI PartsDCI International, LLCECB2026-06-26
00810230800390DCI PartsDCI International, LLCECB2026-06-26
00810230800406DCI PartsDCI International, LLCECB2026-06-26