Device typeCustom-made organ/bone anatomy model: A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.
FDA categoryDriver, Wire, And Bone Drill, Manual, System, Image Processing, Radiological
Device ID00810007631462
Catalog numberMC-3D215
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information