SENOMARK® ULTRA Breast Tissue Marker, 9 Ga ATEC, Titanium Ribbon


Product Overview

SENOMARK® ULTRA Breast Tissue Marker, 9 Ga ATEC, Titanium Ribbon
SenoMark® Ultra Breast Tissue Marker - SMAT9R


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

  • Handling Environment Temperature - Degrees Celsius
    • 25.00
    • N/A

  • Device Sizes

  • Needle Gauge: 9 Gauge
    • Needle Gauge: 9 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NEU

    Device Name: Marker, Radiographic, Implantable

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: SU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 878.4300

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 10801741032094

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741032097

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741032097

    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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