FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040039373
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700419
Catalog number
5700419
Device description
Bur Block Magnetic 8 Hole
Published
2017-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040039370PackageGS150In Commercial Distribution
00304040039373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404003937010304040039370
00304040039373003040400393733040400393730304040039373

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rackA non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.

Regulatory Flags#

DUNS number
012430880
Device count
1
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
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810230800666DCI PartsDCI International, LLCEIF2026-06-26
00810230800673DCI PartsDCI International, LLCEIF2026-06-26
D2486054630Spandex Advanced Junior/Small (Black)HAGER WORLDWIDE, INC.EIF2026-06-07
D2486054640Spandex Advanced Standard/Med (Pink)HAGER WORLDWIDE, INC.EIF2026-06-07
D2486054651Spandex Advanced - 3 Size Combo Kit- Black (1 Junior/Sm, 1 Standard/Med, 1 LargeHAGER WORLDWIDE, INC.EIF2026-06-07
D2486054661Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large)HAGER WORLDWIDE, INC.EIF2026-06-07
00840456223093JMUJMU DENTAL, INCEIF2026-06-05
00840456223109JMUJMU DENTAL, INCEIF2026-06-05
00840456223116JMUJMU DENTAL, INCEIF2026-06-05
00840456223123JMUJMU DENTAL, INCEIF2026-06-05
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
D248938521Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12