FDA.reportPublic FDA data

Fysh Sunwear

Primary DI
00676190358056
Brand
Fysh Sunwear
Company
WestGroupe Optical Inc
Model
F-2033 BURGUNDY GUN
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
00676190358056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00676190358056006761903580566761903580560676190358056

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
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