FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040131364
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701933
Catalog number
5701933
Device description
Chair Cover
Published
2020-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040131361PackageGS14In Commercial Distribution
30304040131368PackageGS130In Commercial Distribution
10304040131364PrimaryGS10
00304040131367Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404013136120304040131361
3030404013136830304040131368
1030404013136410304040131364
00304040131367003040401313673040401313670304040131367

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table paperA non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
225
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10304040194307Henry Schein570570757057072026-10-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841709108877MidmarkMIDMARK CORPORATIONNRU2026-09-29
00841709108884MidmarkMIDMARK CORPORATIONNRU2026-09-29
10194665008918A-decA-DEC, INC.NRU2026-06-22
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D125780MW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
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10194665007911A-decA-DEC, INC.NRU2025-01-24
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