Device typeRadiological image marker, implantable: A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.
FDA categoryMARKER, RADIOGRAPHIC, IMPLANTABLE
Device ID00801741032370
Catalog numberSMUC10R
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Needle Gauge14 Gauge
SizeNeedle Length, 10 Centimeter