edb86e04-f660-4a9c-b327-c697c8bd1407UpdatePublished32024-09-112023-04-21In Commercial DistributionD721SS1000Unit of UseHIBCCD832SS1001PrimaryHIBCCPlasdentSS100SS100190377184PLASDENT CORPORATION500Single Syringe SleevesfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK20160400012535Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.falseActivePEMDental Barriers And Sleevesfalsefalse