BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R2375, 7.5mm EGS Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories

    Reg #: 1721676 · FEI: 1721676 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721676
    FEI Number
    1721676
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5725 Harold Gatty Dr
    City
    Salt Lake City
    State
    UT
    ZIP
    84116
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172811

    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
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE

    Proprietary Names

    R2375, 7.5mm EGS Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories R2007, EsophyX® Z+ Fastener Delivery Device R2175, 7.5mm EGS Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)