FDA.reportPublic FDA data

UVShield, NoIR, GlareShield

Primary DI
00840313206603
Brand
UVShield, NoIR, GlareShield
Company
Noir Medical Technologies LLC
Model
33_34
Published
2023-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840313206603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840313206603008403132066038403132066030840313206603

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067354084
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840313200137IshieldIshield2023-04-03
00840313205194UVShield, NoIR, GlareShield57_142023-03-23
00840313205217UVShield, NoIR, GlareShield57_162023-03-23
00840313205224UVShield, NoIR, GlareShield57_172023-03-23
00840313205316UVShield, NoIR, GlareShield57_182023-03-23
00840313205330UVShield, NoIR, GlareShield57_192023-03-23
00840313205705UVShield, NoIR, GlareShield57_202023-03-23
00840313205712UVShield, NoIR, GlareShield57_212023-03-23
00840313205750UVShield, NoIR, GlareShield57_222023-03-23
00840313205774UVShield, NoIR, GlareShield57_232023-03-23
00840313205781UVShield, NoIR, GlareShield57_242023-03-23
00840313205811UVShield, NoIR, GlareShield57_302023-03-23
00840313205910UVShield, NoIR, GlareShield57_312023-03-23
00840313206078UVShield, NoIR, GlareShield57_332023-03-23
00840313206283UVShield, NoIR, GlareShield57_33W2023-03-23
00840313206368UVShield, NoIR, GlareShield57_362023-03-23
00840313206399UVShield, NoIR, GlareShield57_36W2023-03-23
00840313206566UVShield, NoIR, GlareShield33_232023-03-23
00840313206573UVShield, NoIR, GlareShield33_242023-03-23
00840313206580UVShield, NoIR, GlareShield33_302023-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158674SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-29
08800348923953Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923960Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923977Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923984Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924028Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924035Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924042Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924059Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924097Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924103Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924110Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924141Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924158Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924165Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924172Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924189Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924196Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924202Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924233Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924240Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924257Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924288Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924332Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924349Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924356Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924363Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924424Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924431Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924448Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29