FDA.reportPublic FDA data

Fysh Sunwear

Primary DI
00676190284690
Brand
Fysh Sunwear
Company
WestGroupe Optical Inc
Model
F-2012 BROWN OAK
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
00676190284690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00676190284690006761902846906761902846900676190284690

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
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
00676190869682Fysh SunwearF-2139 BLACK SNOW LEOPF2139S4005419C2026-01-19
00676190869729Fysh SunwearF-2139 NAVY MARBLEF2139S4015419C2026-01-19
00676190869767Fysh SunwearF-2139 MOCHA SMOKEF2139S4025419C2026-01-19
00676190869804Fysh SunwearF-2135 BLACK PEARLESCF2135S4005321C2026-01-19
00676190869842Fysh SunwearF-2135 NAVY BLOOMF2135S4015321C2026-01-19
00676190869880Fysh SunwearF-2135 FOREST BLOOMF2135S4165321C2026-01-19

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Primary DI, Brand, Company table
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08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
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08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342061061Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342061849Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061856Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061863Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061870Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061887Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061894Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061900Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061917Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061924Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061931Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061948Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061955Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061962Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061979Mad in Italy MAD IN ITALY SRLHQY2026-04-13