BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 2029015 · FEI: 1000160458 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029015
    FEI Number
    1000160458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    687 S Wanamaker Ave
    City
    Ontario
    State
    CA
    ZIP
    91761
    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)