FDA.reportPublic FDA data

DISNEY

Primary DI
00193033332832
Brand
DISNEY
Company
FGX INTERNATIONAL INC.
Model
ASTSN2142.FGX
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
00193033332832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193033332832001930333328321930333328320193033332832

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
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
08800348920976Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920983Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920990Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921003Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921027Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921034Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921065Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921072Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921089Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921119Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921126Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921133Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920464Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920471Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920488Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920495Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920525Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920532Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920549Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920556Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920563Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920570Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20