FDA.reportPublic FDA data

MAX STUDIO

Primary DI
00802807320578
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
00802807357277PrimaryGS10
00802807320578Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802807356812008028073568128028073568120802807356812
00802807357277008028073572778028073572770802807357277
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825224459
Device count
3
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
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
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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