257e8304-bd59-433f-aa7a-1cce3b224a84NewPublished12023-07-132023-07-05In Commercial DistributionB091152030PrimaryHIBCCFlashing Butterfly Fixation Stick1002373249Gulden Ophthalmics Inc.1falsetruefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse64186Ophthalmic examination target holderA supportive device intended to be used during an ophthalmic examination (e.g., general eye test, dynamic retinoscopy, ophthalmoscopy) to hold a patient’s visual target in direct line of sight of the clinician, facilitating clinical observations and measurements along the visual axis. It is designed as a frame to support the visual target (e.g., mobile phone, eye test card) and has an opening through which eye observations are made; it typically includes connectors/clamps for fixation to an ophthalmic examination station and ophthalmic instruments. This device is typically used to help engage the patient when cooperation is difficult (e.g., a child or a person with a disability).falseActiveHPLDevice, Fixation, Ac-Powered, Ophthalmicfalsefalse