FDA.reportPublic FDA data

Elle

Primary DI
00888989180650
Brand
Elle
Company
Charmant USA Inc.
Model
14912
Catalog number
1491254BL
Device description
Elle Blue 54/17 140M Sunglass Women
Published
2022-11-30
Public version status
New
Distribution status
Not 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
00888989180650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888989180650008889891806508889891806500888989180650

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
944350339
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888989130068Elle149041490456BR2022-11-28
00888989065827Eddie Bauer39409P39409P68BL2022-11-23
00888989180988Elle149201492056PK2022-12-01
00888989156334Isaac Mizrahi302593025955RG2022-11-29
00888989180964Elle149201492056BK2022-12-01
00888989180995Elle149211492155BE2022-12-01
00888989180544Elle149091490955RO2022-11-30
00888989156280Isaac Mizrahi302583025855GD2022-11-29
00888989129581Elle148921489255RE2022-11-28
00888989129970Elle149021490253BR2022-11-28
00888989181008Elle149211492155BK2022-12-01
00888989180681Elle149131491354BK2022-12-01
00888989180643Elle149121491254BK2022-11-30
00888989001078Eddie Bauer39407P39407P63TT2022-11-23
00888989001108Eddie Bauer39409P39409P68BK2022-11-23
00888989065933Eddie Bauer39412P39412P58BK2022-11-23
00888989129994Elle149021490253RO2022-11-28
00888989065964Eddie Bauer39413P39413P55BK2023-02-01
00888989065971Eddie Bauer39413P39413P55TT2023-02-01
00888989204592Isaac Mizrahi302693026952BL2022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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