FDA.reportPublic FDA data

Esquire

Primary DI
00754317188097
Brand
Esquire
Company
New York Eye
Model
EQ7918-GLD-58
Device description
EQ-M7918 GOLD 58/14/140
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
00754317188097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754317188097007543171880977543171880970754317188097

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
00754317216479Ernest HemingwayH4741-BLK-572026-08-17
00754317216486Ernest HemingwayH4741-GCR-572026-08-17
00754317218022Ernest HemingwayH4742-BLK-582026-08-17
00754317218039Ernest HemingwayH4742-GUN-582026-08-17
00754317228151Valerie SpencerVS9463-TOR-542026-08-17
00754317228618Marc HunterMH7948-MBK-542026-08-17
00754317228625Marc HunterMH7948-MTO-542026-08-17
00754317228632Marc HunterMH7949-MBK-502026-08-17
00754317228649Marc HunterMH7949-MTO-502026-08-17
00754317228656Valerie SpencerVS9464-BKC-552026-08-17
00754317228663Valerie SpencerVS9464-EME-552026-08-17
00754317228670Valerie SpencerVS9465-BKR-552026-08-17
00754317228687Valerie SpencerVS9465-CRT-552026-08-17
00754317228694Valerie SpencerVS9466-BLK-542026-08-17
00754317228731Ernest HemingwayH4743-BLK-532026-08-17
00754317228748Ernest HemingwayH4743-TOR-532026-08-17
00754317228700Valerie SpencerVS9466-CRY-542026-02-20
00754317187878EsquireEQ7903-BLK-532024-06-06
00754317187885EsquireEQ7903-TOR-532024-06-06
00754317187892EsquireEQ7904-BLK-502024-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158353SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158360SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158377SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158391SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158407SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158414SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158421SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158438SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158445SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158452SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158469SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158476SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158483SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158490SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158506SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158513SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158520SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158537SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158544SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158551SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158568SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158575SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158582SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158599SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158605SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158612SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158629SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158636SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
16973541158312SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
16973541158329SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24