BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8MM Sureform 30 Reload, White - 48230W

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    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
    K211997

    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
    Staple, Implantable GDW

    Proprietary Names

    8MM Sureform 30 Reload, White - 48230W 8MM Sureform 30 Reload, Blue - 48230B 8MM Sureform 30 Instrument, Straight Tip - 488430 8MM Sureform 30 Instrument, Curved Tip - 488530 8MM Sureform 30 Reload, Gray - 48230M

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)