FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040127879
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701885
Catalog number
5701885
Device description
Ear Washer - Rigid Tube, 3 Tips, IFU
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCPSYRINGE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040127879PrimaryGS10
00304040127872Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404012787910304040127879
00304040127872003040401278723040401278720304040127872

GMDN Terms#

Term, Definition table
TermDefinition
Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the fungus Coccidioides immitis in a clinical specimen, using an enzyme immunoassay (EIA) method.

Regulatory Flags#

DUNS number
012430880
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040058084Henry Schein112673611267362019-11-26
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.KCP2025-12-15
16971919460494Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-17
16971919460432Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-11
00661392001855LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392010437LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392012486LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392027701LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00194613021535MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00194613112639MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00757770410651Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435401Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435999Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770436620Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770457588Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00661392010444LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392010451LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392010802LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392013414LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392045392LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010441LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010458LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010809LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392013411LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392045399LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00370275092025FS Dispenser, StainlessForward Science Technologies LLCKCP2024-10-14
EDET031591mixing cannulas optima lilac 50 pcs.DETAX GmbHKCP2024-08-28
EDET031601mixing cannulas optima lilac 100 pcs.DETAX GmbHKCP2024-08-28
EDET041941mixing cannulas Automix 2 T-Mixer yellow 25 pcsDETAX GmbHKCP2024-08-28
00714646000576OtoClear Tip SampleBionix, LLCKCP2024-07-11
00840183511951BR Surgical, LLCBR Surgical, LLCKCP2024-06-10