325fc01c-9a01-44ad-8606-848201afb456NewPublished12022-05-182022-05-10In Commercial Distribution00089937554565Unit of UseGS100089937000000PrimaryGS1Wink-EaseUltra Gold 300ct054375491Lt Acquisition, Inc.300falsetruefalsefalsefalsetruefalsefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue64274Epiocular radiation shield, single-useAn opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a single-use device.falseActiveHOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)falsefalse