FDA.reportPublic FDA data

POLAR OPTICS

Primary DI
00000888831826
Brand
POLAR OPTICS
Company
FGX INTERNATIONAL INC.
Model
10601883.NVI
Published
2022-06-28
Public version status
Update
Distribution status
Not 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
00000888831826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00000888831826000008888318260008888318260000888831826

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(401)231-3800Customerservices@fgxi.com

Regulatory Flags#

DUNS number
062312087
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00400000846316DISNEY THEME PARK10235644.DIS2022-06-28
00612409937469VERSANT SALSA10307139.VER2022-06-22
00612409940322VERSANT ROBERT MITCHEL10307203.VER2022-06-22
00612409941268VERSANT VALUE10306769.VER2022-06-22
00612409941541VERSANT SPLENDOR10307620.VER2022-06-22
00832886209624VERSANT CATERPILLAR10306749.VER2022-06-22
00832886209631VERSANT CATERPILLAR10306750.VER2022-06-22
00832886301359VERSANT CATERPILLAR10307313.VER2022-06-22
00612409942036VERSANT VALUE10307574.VER2022-06-22
00612409943996VERSANT VALUE10307362.VER2022-06-22
00832886301199VERSANT CATERPILLAR10306836.VER2022-06-22
00000888832458XTRAVISION5013583-125.NVI2022-06-28
00000888832465XTRAVISION5013583-150.NVI2022-06-28
00000888832472XTRAVISION5013583-175.NVI2022-06-28
00000888832489XTRAVISION5013583-200.NVI2022-06-28
00000888832496XTRAVISION5013583-250.NVI2022-06-28
00000888832502XTRAVISION5013583-300.NVI2022-06-28
00000888832519XTRAVISION5013582-125.NVI2022-06-28
00000888832526XTRAVISION5013582-150.NVI2022-06-28
00000888832533XTRAVISION5013582-175.NVI2022-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977551440818No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440825No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440955No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440962No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
06977198050015DuyingTaizhou Duying GLASSES Co., Ltd.HQY2026-10-24
08800348923892Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923915Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923922Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923939Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923946Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
06973541158643REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158650REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158667REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
16973541158336SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
16973541158343SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158166SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158173SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158180SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158197SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158203SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158210SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158333SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158340SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
08800348923779Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923786Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923793Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923809Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923816Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923823Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923830Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20