FDA.reportPublic FDA data

Islander Eyes

Primary DI
00083758314438
Brand
Islander Eyes
Company
Cliff Weil, Inc.
Model
443
Catalog number
443
Device description
ISLANDER EYES 443 POLARIZED SUNGLASSES
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00083758314438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083758314438000837583144380837583144380083758314438

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
007941511
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00083758000010Regency000100012022-10-27
00083758000065Regency000600062022-10-27
00083758000553Regency005500552022-10-27
00083758000560Regency005600452022-10-27
00083758000591Regency005900592022-10-27
00083758000652Regency006500652022-10-27
00083758001307Regency013001302022-10-27
00083758001376Regency013701372022-10-27
00083758002519Just A Shade Smaller3513512022-10-27
00083758002731Just A Shade Smaller3733732022-10-27
00083758002748Just A Shade Smaller3743742022-10-27
00083758002779Just A Shade Smaller3773772022-10-27
00083758006951Just A Shade SmallerJASS695JASS6952022-10-27
00083758009983Just A Shade SmallerJASS998JASS9982022-10-27
00083758010002RegencyREG1000REG10002022-10-27
00083758011986Just A Shade SmallerJASS1198JASS11982022-10-27
00083758012006RegencyREG1200REG12002022-10-27
00083758012990RegencyREG1299REG12992022-10-27
00083758014000RegencyREG1400REG14002022-10-27
00083758014994RegencyREG1499REG14992022-10-27

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
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01