FDA.reportPublic FDA data

MAX STUDIO

Primary DI
00802807356812
Brand
MAX STUDIO
Company
Evolutioneyes, Inc.
Model
4348 MS TRAVEL STAMPS
Device description
READER 3 PACK
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
HOISpectacle, magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802807356812PrimaryGS10
00802807320578Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802807356812008028073568128028073568120802807356812
00802807320578008028073205788028073205780802807320578

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Regulatory Flags#

DUNS number
825224459
Device count
3
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
00757770433667Bausch + LombBausch & Lomb IncorporatedHOI2025-10-13
00628120772388AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772395AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772425AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772753AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772791AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772814AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772821AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772838AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772852AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772869AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772890AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773583AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773590AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773620AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773835AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773842AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773859AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773873AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773880AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773903AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773910AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773927AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773934AYA OpticalClaudia Alan IncHOI2025-01-18
07640288790618read onRead On Inc.HOI2023-12-08
07640288790625read onRead On Inc.HOI2023-12-08
07640288790632read onRead On Inc.HOI2023-12-05
07640288790649read onRead On Inc.HOI2023-12-05
07640288790656read onRead On Inc.HOI2023-12-05
07640288790663read onRead On Inc.HOI2023-12-05