FDA.reportPublic FDA data

Trifocus

Primary DI
00842894114339
Brand
Trifocus
Company
Diversified Products, Inc.
Model
2201-100-ME
Published
2022-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00842894114339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842894114339008428941143398428941143390842894114339

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
604170506
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842894147702Trifocus BlueBX2201-1252022-12-05
00842894147719Trifocus BlueBX2201-1502022-12-05
00842894147726Trifocus BlueBX2201-1752022-12-05
00037741290032Clear Readers2900-1752022-11-30
00037741290049Clear Readers2900-2002022-11-30
00037741290056Clear Readers2900-2252022-11-30
00037741290063Clear Readers2900-2502022-11-30
00037741290070Clear Readers2900-2752022-11-30
00037741290087Clear Readers2900-3002022-11-30
00037741290094Clear Readers2900-3502022-11-30
00037741405009Sportex4050-1002022-11-30
00037741405016Sportex4050-1252022-11-30
00037741405023Sportex4050-1502022-11-30
00037741405030Sportex4050-1752022-11-30
00037741405047Sportex4050-2002022-11-30
00037741405054Sportex4050-2252022-11-30
00037741405061Sportex4050-2502022-11-30
00037741405078Sportex4050-2752022-11-30
00037741405085Sportex4050-3002022-11-30
00037741406006Sportex4060-1002022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770410873Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770415496Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770425211Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00681131104302EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104333EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104340EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104357EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104364EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104371EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104388EquateWAL-MART STORES, INC.HOI2025-03-07
00802807320752NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320776MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320769MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320745NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320714NICOLE MILLEREvolutioneyes, Inc.HOI2024-06-26
00802807320653MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320660MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320677MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320738M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320691MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320707MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320684MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807357499ESPECEvolutioneyes, Inc.HOI2024-06-26
00802807320486EVOLUTIONEYESEvolutioneyes, Inc.HOI2024-05-14
00802807320578MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320530M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320493MAX EDITIONEvolutioneyes, Inc.HOI2024-05-14
00802807320554NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320646NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320592MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14