114c27a3-9430-4caf-a5a9-b6914d69f409UpdatePublished52023-12-152018-10-29In Commercial Distribution04056719002060PrimaryGS104056719002169Unit of UseGS1Fraxion™P10106-3003145466643C-Medical Intelligence GmbH10The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK11221000061128Stereotactic radiosurgical/radiotherapy arch head frameA non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and neck. It is in the form of an arched frame to which can be attached various components (e.g., mouthpiece, nasion cushion) that non-invasively contact the patient to serve as points of reference, and which is typically attached to a base plate, couch top, or overlay. This is a reusable device.falseActiveIYEAccelerator, Linear, MedicalStorage Environment TemperatureStorage Environment HumidityHandling Environment TemperatureHandling Environment Humidityfalsefalse