FDA.reportPublic FDA data

MAX EDITION

Primary DI
00802807356270
Brand
MAX EDITION
Company
Evolutioneyes, Inc.
Model
4294 CR ME SUNS
Device description
SINGLE SUNGLASS
Published
2023-12-12
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
00802807356270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802807356270008028073562708028073562700802807356270

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

Regulatory Flags#

DUNS number
825224459
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802807357338NICOLE MILLER4400 NM 3 PACK2024-07-03
00802807357505MAX STUDIO4417 MS HARVEST WREATH2024-07-03
00802807357536MAX STUDIO4420 MS BATIK2024-07-03
00802807357895NICOLE MILLER4456 NM DISCO BALL2024-07-03
00802807320752NICOLE MILLER4400 NM 3 PACK2024-07-03
00802807320776MAX STUDIO4417 MS HARVEST WREATH2024-07-03
00802807320769MAX STUDIO4420 MS BATIK2024-07-03
00802807320745NICOLE MILLER4456 NM DISCO BALL2024-07-03
00802807356997NICOLE MILLER4366 NM MUSHROOM CRD2024-06-26
00802807357123MAX STUDIO4379 MS DAHLIA2024-06-26
00802807357130MAX STUDIO4380 MS Wonderland2024-06-26
00802807357154MAX STUDIO4382 MS PUMPKIN2024-06-26
00802807357277MAX STUDIO4348 MS TRAVEL STAMPS2024-06-26
00802807357284M BY MAX STUDIO4394 M BY MAX MARBLE BX2024-06-26
00802807357291MAX STUDIO4396 MS DAMASK CRD2024-06-26
00802807357345MAX STUDIO4401 MS WAVY GEO BX2024-06-26
00802807357451MAX STUDIO4412 MS VIBRANT FLORAL2024-06-26
00802807320714NICOLE MILLER4366 NM MUSHROOM CRD2024-06-26
00802807320653MAX STUDIO4379 MS DAHLIA2024-06-26
00802807320660MAX STUDIO4380 MS Wonderland2024-06-26

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
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13