e80f8e79-a490-44b4-90d9-a5eeebee8ce0UpdatePublished62024-09-022015-10-24In Commercial Distribution00821925016002PrimaryGS1Gyrus ACMI140638007198742Gyrus ACMI, LLC1SHEA PLAT-FLPL CP PIST falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1(800)262-3540xxx@xxx.xxxK76043300033310Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.trueActiveETAReplacement, Ossicular Prosthesis, Totaltruefalse