BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    StabiliT ER2 Bone Cement and Saturate Mixing System

    Reg #: 9616662 · FEI: 3000335778 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MERIT MEDICAL IRELAND, LTD
    Registration Number
    9616662
    FEI Number
    3000335778
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parkmore Business Park West
    City
    Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K072496

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC.
    Contact Name
    John Knorpp
    Address
    1600 WEST MERIT PKWY.
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    StabiliT ER2 Bone Cement and Saturate Mixing System StabiliT VP Vertebrosplasty Kit StabiliT MX Fracture Kits with PowerCURVE StabiliT VP Fracture Kits StabiliT MX Fracture Kits StabiliT Bone Cement and Saturate Mixing System

    Establishment Types

    Repack or Relabel Medical Device