FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040127869
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701883
Catalog number
5701883
Device description
Ear Wash Tips, 20 Tips
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FNYBASIN, EMESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30304040127866PackageGS110In Commercial Distribution
20304040127869PrimaryGS10
00304040127865Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030404012786630304040127866
2030404012786920304040127869
00304040127865003040401278653040401278650304040127865

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, reusableA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.

Regulatory Flags#

DUNS number
012430880
Device count
20
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918130552AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2026-04-17
10198956251335CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251342CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251359CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
10198956138193CARDINAL HEALTHCardinal Health 200, LLCFNY2025-11-07
00661392001176LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012356LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012752LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392037977LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392053823LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392055063LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
10198956137714CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
16931918189192AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918190082AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918129310AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918140827AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918145464AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918146843Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918157085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00661392008083LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392025493LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392045330LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392027664LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
00661392004627LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
10198956044890CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
10197106833780CARDINAL HEALTHCardinal Health 200, LLCFNY2024-12-31
10840330701355ProCureTwin Med, LLCFNY2024-11-14
10840330701362ProCureTwin Med, LLCFNY2024-11-14
10840330701379ProCureTwin Med, LLCFNY2024-11-14
10840330701386ProCureTwin Med, LLCFNY2024-11-14