BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    X-Tack Endoscopic HeliX Tacking System

    Reg #: 3010432890 · FEI: 3010432890 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics Costa Rica S.R.L.
    Registration Number
    3010432890
    FEI Number
    3010432890
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zona Franca PROPARK, Calle Principal, Edificio 10
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K201808

    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
    Hemostatic Metal Clip For The Gi Tract PKL
    Endoscopic Tissue Approximation Device OCW

    Proprietary Names

    X-Tack Endoscopic HeliX Tacking System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)