FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040051822
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007979
Catalog number
9007979
Device description
Universal Curing Light Shield
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040051829PackageGS148In Commercial Distribution
10304040051822PrimaryGS10
00304040051825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404005182920304040051829
1030404005182210304040051822
00304040051825003040400518253040400518250304040051825

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding goggles/spectaclesA personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.

Regulatory Flags#

DUNS number
012430880
Device count
400
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008137SAFEVIEWHealth Care Logistics, Inc.HOY2026-07-10
00860009651647KC Eye Tape - 50 PairsKelCor, LLCHOY2026-07-10
00840456222867JMUJMU DENTAL, INCHOY2026-07-07
00840456222874JMUJMU DENTAL, INCHOY2026-07-07
D125720C4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720CR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720T4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
00630094055190Bioseal Inc.BIOSEALHOY2024-01-29
00630094404721Bioseal Inc.BIOSEALHOY2024-01-29
00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
00630094540474Bioseal Inc.BIOSEALHOY2024-01-29
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29