FDA.reportPublic FDA data

One True Pair Sun

Primary DI
00676190875669
Brand
One True Pair Sun
Company
WestGroupe Optical Inc
Model
OTPS-2065 CREAM
Catalog number
OTPS2065S3185421C
Device description
Sunglasses ( tinted non-prescription spectacles )
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00676190875669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00676190875669006761908756696761908756690676190875669

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-361-6220customerservice@westgroupe.com

Regulatory Flags#

DUNS number
204096080
Device count
1
Premarket exempt
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
00676190869682Fysh SunwearF-2139 BLACK SNOW LEOPF2139S4005419C2026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04582647307972MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307989MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307996MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308146MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308153MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308160MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308313MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308320MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308375MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308382MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308399MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308405MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308412MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308429MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308436MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308443MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308450MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308467MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308559MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308566MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308573MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308641MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308658MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
08800348920907Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920914Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920921Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920938Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920945Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920952Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920969Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22