BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Interlink System Stopcock with Extension Set, 5.8 mL

    Reg #: 1423662 · FEI: 3000215273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1423662
    FEI Number
    3000215273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Lakeside Drive
    City
    Gurnee
    State
    IL
    ZIP
    60031
    Country
    US

    Regulatory Submissions

    510(k) Number
    K962581

    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
    Stopcock, I.V. Set FMG

    Proprietary Names

    Interlink System Stopcock with Extension Set, 5.8 mL Interlink Continu-Flo Set, 10 DPM Larg Bore 4 Way Elcam Stopcock Ext. Set Interlink Continu-Flo Set with 4-Way Elcam Stopcock Continu-Flo Set Basic Solution Set, 10 Solution Set 4-Way Stopcock with Rotating Male Luer Lock Adapter Interlink Continu-Flo Set, 10 4-Way Stopcocks and 33" Removable Ext. Interlink T-Connector Extension Set Clearlink System Continu-Flo Soln Set, 10 DPM Lg Bore 4-Way Stopcock Ext. Set Interlink Solution Set with Elcam Polysulfone Stopcock Stopcock with Extension Set Novex 3-Way Stopcock with MLS Adapter Detachable Interlink Inj. Site Solution Set, 10 3-Way Elcam Polysulfaone Stopcock with Ext. Tubing Luer Lock Adapter 1C8325 - Stopcock Minivolume Extension Set 3 Way Stopcock w/Rotating Male Luer Lock Adapter 3-Way Stopcock with Ext. Tubing Luer Lock Adapter Interlink Continu-Flo Set Continu-Flo Solution Set Interlink System with Elcam Polysulfone Stopcock w/Extension Stopcock Extension Set Interlink Continu-Flo R Set, 10 with 3-Way Elcam Polysulfone Stopcock Clearlink System Continu-Flo Solution Set Mini Volume Extension Stopcock Manifold Gangs

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)