FDA.reportPublic FDA data

STEVE MADDEN

Primary DI
00193033417133
Brand
STEVE MADDEN
Company
FGX INTERNATIONAL INC.
Model
10257508.LTS
Published
2022-01-30
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
00193033417133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193033417133001930334171331930334171330193033417133

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
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
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
08908016666505SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666529SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666536SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666635SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13