FDA.reportPublic FDA data

Sunglass

Primary DI
08908016666451
Brand
Sunglass
Company
PRAMARA PROMOTIONS LIMITED
Model
6223 BLK
Device description
SUNGLASS, 6223, BLACK
Published
2026-05-22
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
08904527200009PackageGS1300In Commercial Distribution
08908016666451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904527200009089045272000098904527200009
08908016666451089080166664518908016666451

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.

Regulatory Flags#

DUNS number
771460561
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908016666505Sunglass6224 BLUBLK2026-05-29
08908016666529Sunglass6224 LIMBLK2026-05-29
08908016666536Sunglass6224 ORNBLK2026-05-29
08908016666635Sunglass6223BRTYEL2026-05-29
08908016666468Sunglass6223 NAV2026-05-22
08908016666475Sunglass6223 RED2026-05-22
08908016666482Sunglass6223 ROY2026-05-22
08908016666499Sunglass6223 WHT2026-05-22
08908016666642Sunglass6223CBL2026-05-22
08908016666659Sunglass6223GRA2026-05-22
08908016666666Sunglass6223GRK2026-05-22
08908016666673Sunglass6223PUR2026-05-22
08908016666840Sunglass6208WHTBLU2026-05-22
08908016666857Sunglass6208WHTGRN2026-05-22
08908016666864Sunglass6208WHTSIL2026-05-22
08908016666871Sunglass6208WHTYEL2026-05-22
08908016666581Sunglass6207CLRBLU2026-05-08
08908016666598Sunglass6207CLRGRN2026-05-08
08908016666604Sunglass6207CLRRED2026-05-08
08908016666611Sunglass6207CLRSIL2026-05-08

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
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