BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Twist & Go, HPCT, 30''

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131517

    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
    Tubing, Fluid Delivery FPK

    Proprietary Names

    Twist & Go, HPCT, 30'' TAG C75 HPCT Twist-and-Go High Pressure Connector Tube 75 cm TAG C150 HPCT Twist-and-Go High Pressure Connector Tube 150 cm Twist & Go, HPCT, 48'' Twist & Go Disposable Syringe 150 ml with Quick Fill Tube TAG 150 SYR Twist & Go, HPCT, 60'' Twist & Go Disposable Syringe Kit Twist & Go HPCT, 20'' TAG C120 HPCT Twist-and-Go High Pressure Connector Tube 120 cm Twist-and-Go High Pressure Connector Tube 50 cm (TAG C50 HPCT) TAG C50 HPCT Twist-and-Go High Pressure Connector Tube 50 cm Twist-and-Go High Pressure Connector Tube 75 cm (TAG C75 HPCT) Twist-and-Go High Pressure Connector Tube 150 cm (TAG C150 HPCT) TAG 150 SYR Twist-and-Go High Pressure Connector Tube 120 cm (TAG C120 HPCT) Medrad Twist a& Go Syringe Kit (TAG 150 SYR)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)