FDA.report

UVShield, NoIR, GlareShield

Primary DI
00840313208263
Brand
UVShield, NoIR, GlareShield
Company
Noir Medical Technologies LLC
Model
43_17
Published
2023-03-23
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
false

Related Records

Product Codes

CodeName
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840313208263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840313208263008403132082638403132082630840313208263

GMDN Terms

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

Regulatory Flags

DUNS number
067354084
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 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 DIBrandCompanyProduct codePublished
06973541158162SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158179SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158186SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158193SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158209SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158216SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158223SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158230SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158247SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158254SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158261SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158278SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158285SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158292SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158308SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
08800332269531Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269548Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269586Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269593Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269616Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269623Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269630Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269647Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269654Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269661Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269678Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269685Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269692Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269708Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269715Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22