BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SP1098 Entry Guide - 430022

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182371

    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
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    SP1098 Entry Guide - 430022 SP Camera Instrument Sheath - 430020 SP Instrument Sheath - 430012 SP Monopolar Scissors Tip - 430035 SP Drape - 430013

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)