Fiducial Marker;3-Band


Product Overview

Fiducial Marker;3
superDimension - SDM3


Device Description

A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital 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.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep dry

  • Device Sizes

  • Outer Diameter: 0.9 Millimeter
  • Length: 23 Millimeter
    • Outer Diameter: 0.9 Millimeter
    • Length: 23 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: IYE

    Device Name: Accelerator, Linear, Medical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 892.5050

    Third Party Flag: N

    Medical Specialty: RA


    Device Identifiers

    Device Id: 20884521198804

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521198807

    Package Quantity: 5

    Package Discontinue Date: 4/6/2018 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CASE


    Device Id: 10884521198807

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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