FDA.reportPublic FDA data

UVShield, NoIR, GlareShield

Primary DI
00840313205781
Brand
UVShield, NoIR, GlareShield
Company
Noir Medical Technologies LLC
Model
57_24
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
00840313205781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840313205781008403132057818403132057810840313205781

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
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
00840313206597UVShield, NoIR, GlareShield33_312023-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977551440818No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440825No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440955No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440962No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
06977198050015DuyingTaizhou Duying GLASSES Co., Ltd.HQY2026-10-24
08800348923892Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923915Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923922Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923939Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923946Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
06973541158643REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158650REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158667REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
16973541158336SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
16973541158343SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158166SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158173SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158180SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158197SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158203SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158210SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158333SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158340SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
08800348923779Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923786Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923793Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923809Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923816Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923823Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923830Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20