FDA.reportPublic FDA data

MAX EDITION

Primary DI
00802807357185
Brand
MAX EDITION
Company
Evolutioneyes, Inc.
Model
4385 FS ME
Device description
SINGLE SUNGLASS
Published
2024-05-14
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
00802807357185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802807357185008028073571858028073571850802807357185

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
04580822704165EYEVANEYEVAN INC.HQY2026-07-10
04580822704172EYEVANEYEVAN INC.HQY2026-07-10
04580822704189EYEVANEYEVAN INC.HQY2026-07-10
04580822704196EYEVANEYEVAN INC.HQY2026-07-10
04580822704660EYEVANEYEVAN INC.HQY2026-07-10
04580822704677EYEVANEYEVAN INC.HQY2026-07-10
04580822704684EYEVANEYEVAN INC.HQY2026-07-10
04580822704691EYEVANEYEVAN INC.HQY2026-07-10
04580822704707EYEVANEYEVAN INC.HQY2026-07-10
04580822705148EYEVANEYEVAN INC.HQY2026-07-10
04580822705155EYEVANEYEVAN INC.HQY2026-07-10
04580822705162EYEVANEYEVAN INC.HQY2026-07-10
04580822705179EYEVANEYEVAN INC.HQY2026-07-10
04580822705186EYEVANEYEVAN INC.HQY2026-07-10
04580822705193EYEVANEYEVAN INC.HQY2026-07-10
04580822705223EYEVANEYEVAN INC.HQY2026-07-10
04580822705230EYEVANEYEVAN INC.HQY2026-07-10
04582669067885E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067892E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067908E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067915E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067922E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068417E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068424E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068455E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068462E5 eyevanEYEVAN INC.HQY2026-07-10
04582669069384EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069391EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069407EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069582EYEVAN7285EYEVAN INC.HQY2026-07-10