FDA.reportPublic FDA data

BLUEOTTER

Primary DI
08012794011461
Brand
BLUEOTTER
Company
LA GIARDINIERA SRL
Model
PLASTIC SUNGLASSES
Device description
PLASTIC FRAME WITH SUNLENSES
Published
2023-01-05
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
08012794011461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08012794011461080127940114618012794011461

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
428689665
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08012794011942ANGELEONEPLASTIC SUNGLASSES2024-10-05
08012794011959LIFE ITALIANI158 C12024-10-05
08012794011966LIFE ITALIANI158 C22024-10-05
08012794011973LIFE ITALIANI158 C32024-10-05
08012794011980LIFE ITALIANI161 C12024-10-05
08012794011997LIFE ITALIANI161 C22024-10-05
08012794012000LIFE ITALIANI161 C32024-10-05
08012794012017VELENCIPLASTIC SUNGLASSES2024-10-05
08012794012024MUSESPLASTIC SUNGLASSES2024-10-05
08012794011935BREAKLINEPLASTIC SUNGLASSES2023-12-11
08012794011898LIFE ITALIANI157 C12023-11-24
08012794011904LIFE ITALIANI157 C22023-11-24
08012794011911LIFE ITALIANI157 C32023-11-24
08012794011744LIFE ITALIANI154 C12023-10-10
08012794011751LIFE ITALIANI154 C22023-10-10
08012794011768LIFE ITALIANI154 C32023-10-10
08012794011775LIFE ITALIANI155 C12023-10-10
08012794011782LIFE ITALIANI155 C22023-10-10
08012794011799LIFE ITALIANI155 C32023-10-10
08012794011805LIFE ITALIANI156 C12023-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209038196FielmannFielmann Group AGHQY2026-07-06
04066209038202FielmannFielmann Group AGHQY2026-07-06
04066209038219FielmannFielmann Group AGHQY2026-07-06
04066209053885FielmannFielmann Group AGHQY2026-07-06
04066209060180FielmannFielmann Group AGHQY2026-07-06
04066209060197FielmannFielmann Group AGHQY2026-07-06
04066209060203FielmannFielmann Group AGHQY2026-07-06
04066209060265FielmannFielmann Group AGHQY2026-07-06
04066209060289FielmannFielmann Group AGHQY2026-07-06
04066209060388FielmannFielmann Group AGHQY2026-07-06
04066209060470FielmannFielmann Group AGHQY2026-07-06
04066209060845FielmannFielmann Group AGHQY2026-07-06
04066209061132FielmannFielmann Group AGHQY2026-07-06
04066209063570FielmannFielmann Group AGHQY2026-07-06
04066209064416FielmannFielmann Group AGHQY2026-07-06
04066209064430FielmannFielmann Group AGHQY2026-07-06
04066209064874FielmannFielmann Group AGHQY2026-07-06
06973541158131SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
16973541158138SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
06974213566148MalibuWENZHOU TIDE-OPTICAL CO.,LTDHQY2026-07-03
08800348920280Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920297Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920303Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920310Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920327Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920334Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920341Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920358Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920365Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920372Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25