FDA.reportPublic FDA data

BOLT&ARROW

Primary DI
08012794011478
Brand
BOLT&ARROW
Company
LA GIARDINIERA SRL
Model
PLASTIC SUNLENSES
Device description
PAIR OF SPARE SUNLENSES
Published
2023-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQGLens, Spectacle, Non-Custom (Prescription)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQGLens, Spectacle, Non-Custom (Prescription)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08012794011478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08012794011478080127940114788012794011478

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

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
00054917321697Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321703Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321840Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321857Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339777Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339791Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340247Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340261Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340278Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340292Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340308Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345914Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345938Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345945Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917347673Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821163Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821170Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821187Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821194Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821200Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821217Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821224Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821231Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821248Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821255Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821262Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821279Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821286Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821293Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478825475Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25