FDA.reportPublic FDA data

Valerie Spencer

Primary DI
00754317228670
Brand
Valerie Spencer
Company
New York Eye
Model
VS9465-BKR-55
Device description
VS-9465 BLACK/RED 55/17/145
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00754317228670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754317228670007543172286707543172286700754317228670

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).

Regulatory Flags#

DUNS number
021529771
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00754317187908EsquireEQ7904-MBK-502024-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00754317216479Ernest HemingwayNew York EyeHQY2026-08-17
00754317216486Ernest HemingwayNew York EyeHQY2026-08-17
00754317218022Ernest HemingwayNew York EyeHQY2026-08-17
00754317218039Ernest HemingwayNew York EyeHQY2026-08-17
00754317228151Valerie SpencerNew York EyeHQY2026-08-17
00754317228618Marc HunterNew York EyeHQY2026-08-17
00754317228625Marc HunterNew York EyeHQY2026-08-17
00754317228632Marc HunterNew York EyeHQY2026-08-17
00754317228649Marc HunterNew York EyeHQY2026-08-17
00754317228656Valerie SpencerNew York EyeHQY2026-08-17
00754317228663Valerie SpencerNew York EyeHQY2026-08-17
00754317228687Valerie SpencerNew York EyeHQY2026-08-17
00754317228694Valerie SpencerNew York EyeHQY2026-08-17
00754317228731Ernest HemingwayNew York EyeHQY2026-08-17
00754317228748Ernest HemingwayNew York EyeHQY2026-08-17
08800348923403Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923410Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923427Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923441Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923458Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923465Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923496Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923502Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923519Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
06980076270009GaoqiuTaizhou Gaoqiu Glasses Co., Ltd.HQY2026-08-07
08800332263010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263041Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263584Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263614Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264765Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31