FDA.reportPublic FDA data

Fysh Sunwear

Primary DI
00676190265989
Brand
Fysh Sunwear
Company
WestGroupe Optical Inc
Model
F-2004 BLACK HAVANA
Published
2020-07-09
Public version status
Update
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
00676190265989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00676190265989006761902659896761902659890676190265989

GMDN Terms#

Term, Definition table
TermDefinition
Tinted spectacles, non-prescriptionAn optical device that consists of a spectacle frame or clips made of metal and/or plastic materials that contains a pair of tinted spectacle lenses (typically made of plastic or glass) that are worn in front of the user's eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light, but not to provide refractive corrections. This device is normally available [non-prescription] over-the-counter (OTC).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204096080
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00676190876697Superflex Sun CollectionSFS-2038 GREYSFS2038M1035616C2026-06-01
00676190876734Superflex Sun CollectionSFS-2038 NAVY BLUESFS2038M1015616C2026-06-01
00676190876772Superflex Sun CollectionSFS-2038 MATTE BLACKSFS2038M1005616C2026-06-01
00881814539937Superflex Sun CollectionSFS-2039 BLACKSFS2039S3005120C2026-06-01
00881814539975Superflex Sun CollectionSFS-2039 PURPLESFS2039S3075120C2026-06-01
00881814540018Superflex Sun CollectionSFS-2039 DEMI AMBERSFS2039S4125120C2026-06-01
00676190886696Superflex Sun CollectionSFS-2037 ROSE TORTSFS2037S4095518C2026-04-20
00676190886733Superflex Sun CollectionSFS-2037 BLUE TORTSFS2037S4015518C2026-04-20
00676190886771Superflex Sun CollectionSFS-2037 TORTOISESFS2037S4125518C2026-04-20
00676190867831Superflex Sun CollectionSFS-2032 DUSTY ROSE TORTSFS2032S4095020C2026-03-02
00676190867879Superflex Sun CollectionSFS-2032 BLUE TORTSFS2032S4015020C2026-03-02
00676190867916Superflex Sun CollectionSFS-2032 BLACK IVORYSFS2032S3005020C2026-03-02
00676190867954Superflex Sun CollectionSFS-2033 ICESFS2033M3135916C2026-03-02
00676190867992Superflex Sun CollectionSFS-2033 MATTE BLACKSFS2033M3005916C2026-03-02
00676190875461One True Pair SunOTPS-2061 M.BLACK TORTOTPS2061M3005022C2026-03-02
00676190875508One True Pair SunOTPS-2061 TEAL AMBEROTPS2061S3045022C2026-03-02
00676190875546One True Pair SunOTPS-2061 TOKYO TORTOTPS2061S4125022C2026-03-02
00676190875584One True Pair SunOTPS-2065 BLACKOTPS2065S3005421C2026-03-02
00676190875621One True Pair SunOTPS-2065 DUSTY ROSEOTPS2065S3095421C2026-03-02
00676190875669One True Pair SunOTPS-2065 CREAMOTPS2065S3185421C2026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800332269982Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
08800332269999Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
08800348923755Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
08800348923762Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
06973541158353SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158360SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158377SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158391SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158407SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158414SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158421SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
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06973541158452SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158469SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158476SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158483SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158490SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158506SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158513SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158520SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158537SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158544SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158551SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158568SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158575SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158582SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158599SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158605SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158612SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24