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    FDA Registration Active 🇺🇸 United States

    SureForm™ 45 (Stapler 45) Reload (Black) - 48345T

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    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
    K183224

    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

    SureForm™ 45 (Stapler 45) Reload (Black) - 48345T SureForm™ 45 (Stapler 45) Reload (Blue) - 48345B SureForm™ 45 (Stapler 45) Reload (White) - 48345W SureForm™ 45 (Stapler 45) Reload (Green) - 48345G SureForm™ 45 (Stapler 45) Reload (Grey) - 48345M SureForm™ 45 (Stapler 45) Straight-Tip Instrument - 480445

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)