FDA.reportPublic FDA data

SOLAR SHIELD

Primary DI
00057800022015
Brand
SOLAR SHIELD
Company
FGX INTERNATIONAL INC.
Model
2X101.SDM
Published
2022-06-22
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
00057800022015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00057800022015000578000220150578000220150057800022015

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
00000888831826POLAR OPTICS10601883.NVI2022-06-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348924455Blue ElephantBlue Elephant Co.,Ltd.HQY2026-11-02
08800348924462Blue ElephantBlue Elephant Co.,Ltd.HQY2026-11-02
08800348924479Blue ElephantBlue Elephant Co.,Ltd.HQY2026-11-02
08800348924486Blue ElephantBlue Elephant Co.,Ltd.HQY2026-11-02
06973541158674SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-29
08800348923953Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923960Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923977Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923984Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924028Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924035Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924042Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924059Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924097Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924103Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924110Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924141Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924158Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924165Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924172Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924189Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924196Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924202Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924233Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924240Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924257Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924288Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924332Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924349Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924356Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29