a7f986dc-cbec-42b3-bb2d-c24399fb94a0NewPublished12021-07-262021-07-16In Commercial Distribution50749756158058PackageGS10074975615805310In Commercial DistributionCase00749756158053PrimaryGS1DeRoyalM60-331M60-331096372255DEROYAL INDUSTRIES, INC.1Custom Surgical Position KittruetruefalsefalsefalsefalsetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(888)938-7828udisupport@deroyal.com62292Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.falseActiveCCXSUPPORT, PATIENT POSITIONfalsefalse