BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMARTFrame MRI-Guided Trajectory Frame

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    2011171
    FEI Number
    2011171
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4900 Gifford Ave
    City
    Los Angeles
    State
    CA
    ZIP
    90058
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160434

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri ORR

    Proprietary Names

    SMARTFrame MRI-Guided Trajectory Frame SMARTFrame XG MRI-Guided Trajectory Frame SF M6 Bolt Driver SMARTFrame Guide Tubes 64” / CP Stylet SMARTFrame Guide Tubes 52” / 18 ga MRII Hex Key SMARTFrame Burr Hole Guide, 14-mm SMARTFrame Accessory Kit VarioGuide Drill Kit Drill Bit 3.4 mm / Device Guide 2.16 mm VarioGuide Drill Kit Drill Bit 3.4 mm / Device Guide 1.9 mm SMARTFrame Hand Controller SmartFrame® Skull Mount Base Centering Tool Guide Assy. (ED-800120) SMARTFrame MRI-Guided Trajectory Tower w/o Base Device Guide, 4.5mm (ED-800129) SMARTFrame Guide Tubes 68” / 16 ga SMARTFrame Centering Tool Guide SMARTFrame XG Exchangeable Device Guides SMARTFrame Guide Tubes 74” / 15 ga SMARTGrid MRI Planning Grid SMARTFrame Guide Tubes 60” / 17 ga SmartTip MRII Drill Kit, 4.5 mm SMARTFrame Scalp Mount Base SMARTFrame Guide Tubes SMARTFrame Scalp Mount Rescue Screw- Short SmartTwist MRII Hand Drill SMARTFrame Scalp Mount Rescue Screw - Long SMARTFrame® Pilot Hole Tool – Skull Mount Base SMARTFrame Thumb Wheel Extension Set SMARTFrame Skull Mount Rescue Screw ClearPoint® MRI Fiducial Markers SmartFrame M6 Bolt Driver SMARTFrame Wharen Centering Guide

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)