FDA.report

Fysh Sunwear

Primary DI
00676190284331
Brand
Fysh Sunwear
Company
WestGroupe Optical Inc
Model
F-2009 BERRY
Published
2020-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00676190284331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00676190284331006761902843316761902843310676190284331

GMDN Terms

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

Regulatory Flags

DUNS number
204096080
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00676190871265Fysh SunwearF-2138 AQUA PURPLEF2138S4045122C2026-01-19
00676190871302Fysh SunwearF-2138 BLACK RS MOSAICF2138S3005122C2026-01-19
00676190871340Fysh SunwearF-2138 MOCHA SHIMMERF2138S4025122C2026-01-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16977551440368HIT PROMOTIONAL PRODUCTS, INC.SANMEN HONGYU GLASSES CO., LTDHQY2026-03-06
16977551440375Gold Bond IncSANMEN HONGYU GLASSES CO., LTDHQY2026-03-06
00676190867831Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867879Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867916Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867954Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867992Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190875461One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875508One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875546One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875584One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875621One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875669One True Pair SunWestGroupe Optical IncHQY2026-03-02
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