FDA.reportPublic FDA data

Henry Schein Essentials

Primary DI
10304040035693
Brand
Henry Schein Essentials
Company
HENRY SCHEIN, INC.
Model
1126952
Catalog number
1126952
Device description
Essentials Cover Film Blue
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PEMDental barriers and sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040035690PackageGS120In Commercial Distribution
10304040035693PrimaryGS10
00304040035696Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404003569020304040035690
1030404003569310304040035693
00304040035696003040400356963040400356960304040035696

GMDN Terms#

Term, Definition table
TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00FALSE

Regulatory Flags#

DUNS number
012430880
Device count
1200
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
B9764488001OptiClear SleevesMinitube ABPEM2026-02-13
B9764488041OptiClear SleevesMinitube ABPEM2026-02-13
B9764488061OptiClear SleevesMinitube ABPEM2026-02-13
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
00618125187126VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187133VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187140VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188710VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188727VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188734VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125189953VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190171VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190188VALOTIDI PRODUCTS, LLCPEM2025-08-29
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
10304040186722AccleanHENRY SCHEIN, INC.PEM2024-10-02
00816577024581Young InfinityYoung Innovations, Inc.PEM2024-09-30
00816577024604DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024611DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024628DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024635DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
20850061028024Dental BasicsDental Basics Inc.PEM2024-05-08
10371347011941Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
10371347011958Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
00816419021617iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021624iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021853iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021860iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021877iSmileIsmile Dental Products, Inc.PEM2023-06-21