FDA.reportPublic FDA data

ICU Eyewear

Primary DI
00078041213468
Brand
ICU Eyewear
Company
ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
Model
20590208Y
Published
2022-12-01
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
00078041213468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078041213468000780412134680780412134680078041213468

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
001952241
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00078041002383ICU Eyewear10580205ZX2022-12-01
00078041003120ICU Eyewear201501012022-12-01
00078041003137ICU Eyewear201501022022-12-01
00078041003144ICU Eyewear201501032022-12-01
00078041003151ICU Eyewear201501042022-12-01
00078041003168ICU Eyewear201501062022-12-01
00078041003175ICU Eyewear201501072022-12-01
00078041003182ICU Eyewear201501082022-12-01
00078041003199ICU Eyewear201501052022-12-01
00078041013884ICU Eyewear503092082022-12-01
00078041014010ICU Eyewear702200082022-12-01
00078041036722ICU Eyewear702200012022-12-01
00078041036739ICU Eyewear702200022022-12-01
00078041036746ICU Eyewear702200032022-12-01
00078041036753ICU Eyewear702200042022-12-01
00078041036777ICU Eyewear702200062022-12-01
00078041048251ICU Eyewear718501022022-12-01
00078041048268ICU Eyewear718501032022-12-01
00078041048275ICU Eyewear718501042022-12-01
00078041048299ICU Eyewear718501062022-12-01

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