FDA.reportPublic FDA data

Esquire

Primary DI
00754317187892
Brand
Esquire
Company
New York Eye
Model
EQ7904-BLK-50
Device description
EQ-M7904 SHINY BLACK 50/21/145
Published
2024-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00754317187892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754317187892007543171878927543171878920754317187892

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021529771
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754317228700Valerie SpencerVS9466-CRY-542026-02-20
00754317187878EsquireEQ7903-BLK-532024-06-06
00754317187885EsquireEQ7903-TOR-532024-06-06
00754317187908EsquireEQ7904-MBK-502024-06-06
00754317187915EsquireEQ7904-MTO-502024-06-06
00754317187922EsquireEQ7904-TOR-502024-06-06
00754317187939EsquireEQ7905-BKC-512024-06-06
00754317187946EsquireEQ7905-TOR-512024-06-06
00754317187984EsquireEQ7907-BLC-532024-06-06
00754317187991EsquireEQ7907-CRY-532024-06-06
00754317188011EsquireEQ7901-TOR-602024-06-06
00754317188028EsquireEQ7908-BLK-532024-06-06
00754317188035EsquireEQ7908-TOR-532024-06-06
00754317188042EsquireEQ7908-CRY-532024-06-06
00754317188059EsquireEQ7917-BRN-572024-06-06
00754317188066EsquireEQ7917-GLD-572024-06-06
00754317188073EsquireEQ7918-BLK-582024-06-06
00754317188080EsquireEQ7918-BRN-582024-06-06
00754317188097EsquireEQ7918-GLD-582024-06-06
00754317188103EsquireEQ7918-GUN-582024-06-06

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