46f43fa4-bc0f-4038-a2d9-e60bccd4fabfNewPublished12022-12-092022-12-01In Commercial Distribution00078041154792PrimaryGS1ICU Eyewear73180404OD001952241ZOOM EYEWORKS DBA ICU EYEWEAR, INC.1falsetruefalsefalsefalsefalsefalsefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue42832Magnifying 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.falseActiveHOISpectacle, magnifyingfalsefalse