BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MONTERIS MEDICAL CORP

    Reg #: 3009970070 · FEI: 3009970070 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    25
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    MONTERIS MEDICAL CORP
    Registration Number
    3009970070
    FEI Number
    3009970070
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    131 Cheshire Lane, Suite 100
    City
    Minnetonka
    State
    MN
    ZIP
    55305
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030172

    Owner / Operator

    Firm Name
    Monteris Medical Corp
    Operator Number
    10042500
    Address
    131 Cheshire Lane Suite 100
    City
    Minnetonka
    State
    MN
    Postal Code
    55305
    Country
    US

    Products

    Device Name Product Code
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Powered Laser Surgical Instrument GEX
    Neurological Stereotaxic Instrument HAW
    Coil, Magnetic Resonance, Specialty MOS
    Neurosurgical Laser With Mr Thermography ONO
    Instrument, Surgical, Non-Powered HAO
    System, X-Ray, Film Marking, Radiographic JAC

    Proprietary Names

    NeuroBlate Optic M-Vision Software M-Vision Pro Fusion Software NeuroBlate M-Vision Pro Software Fusion-S Software Fusion-S NeuroBlate System AutoLITT; NeuroBlate System AtamA System M Vision M Vision Software NB3 Monteris Medical Mini-Bolt Adapters Monteris Medical Mini-Bolt Monteris Medical Cranial Bolt Adapters Monteris Medical Cranial Bolt Monteris AXiiiS CMB Monteris AXiiiS CMB-S Monteris Mini-Bolt -S Monteris Medical Mini-Bolt VUE Cranial Bolt Monteris AXiiiS CMB-V Monteris Medical Mini-Bolt VUE Cranial Bolt Adaptor M-Vision Fusion

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility