e3fc4c30-b703-4118-bd35-edef7733466aNewPublished12020-10-022020-09-24In Commercial Distribution00810050242585PrimaryGS1NA21577081253414DOMICO MED-DEVICE, LLC1PAD, FOREHEAD, .50 X 2.00 X 6.00 falsetruefalsefalsefalsefalsetruefalsetruefalsefalsefalsetrueLabeling does not contain MRI Safety Informationfalsefalse62482Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.falseActive61132Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.falseActiveIWYHolder, Head, RadiographicFMQRestraint, ProtectiveHeightWidthLengthfalsefalse