BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SterCUBE Surgical Systems, LLC

    Reg #: 3012085539 · FEI: 3012085539 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SterCUBE Surgical Systems, LLC
    Registration Number
    3012085539
    FEI Number
    3012085539
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1452 Hughes Rd Ste 200, Pmb 550
    City
    Grapevine
    State
    TX
    ZIP
    76051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152014

    Owner / Operator

    Firm Name
    SteriCUBE Surgical Systems, LLC
    Operator Number
    10050671
    Address
    1452 Hughes Road, Suite 200, PMB #550
    City
    Grapevine
    State
    TX
    Postal Code
    76051
    Country
    US
    Correspondent
    Lisa J Holt

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    MTS300 Transfer Cart, Steris, Standard GETINGE Bridge MTS300 Filter Kit STERIS Bridge MTS300 Transfer Cart, FL, Universal STERIS Evolution Bridge MTS225 Cabinet MTS225 GETINGE Cabinet MTS300 Cabinet, Steris, Standard MTS225 GETINGE Transfer Cart MTS225 TCFL Transfer Cart MTS225 Transfer Cart, Steris 600 MTS225 Cabinet, Steris 600 MTS300 Transfer Cart, Getinge MTS300 Cabinet, Steris, Evolution MTS Filter Kit MTS225 STERIS Transfer Cart MTS300 Transfer Cart, Steris, Evolution MTS300 Floor Loader, Getinge MTS300 Cabinet, Getinge SteriCUBE Filter Kit Plus

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility