FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040132153
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702004
Catalog number
5702004
Device description
Disposable Dental Bib Holder
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NRDUnit, operative dental, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040132153PackageGS140In Commercial Distribution
10304040132156PrimaryGS10
00304040132159Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404013215320304040132153
1030404013215610304040132156
00304040132159003040401321593040401321590304040132159

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D12517802Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517812Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517822Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
00810126506511Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00371347017878Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017885Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017830Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017847Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017854Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017861Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
06971119541897Air compressor Guangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
06971119541903Testing machineGuangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
10194665007935ActeonA-DEC, INC.NRD2025-05-15
D1302HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1303HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1304HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM10BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM20BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D678AS50X1AirStarAIR TECHNIQUES, INC.NRD2025-04-25
D678AS70X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
00304040190371Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190388Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190395Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190401Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21