FDA.reportPublic FDA data

IZUMI Eyewear

Primary DI
00881814503303
Brand
IZUMI Eyewear
Company
WestGroupe Optical Inc
Model
OS-9233 BLACK SILVER
Published
2020-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00881814503303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00881814503303008818145033038818145033030881814503303

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
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
08447504028307ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028345ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028383ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028420ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029342ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029380ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029427ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029465ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031529ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031567ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031604ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031642ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032007ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032045ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032083ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032120ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032168ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032205ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032243ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032281ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035251ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036777ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036814ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036852ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036890ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037897ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037934ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26