BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stellant 60" low pressure connector tubing with 6" "T" connector and Prime Tube

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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
    K082905

    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
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    Stellant 60" low pressure connector tubing with 6" "T" connector and Prime Tube Stellant Single Syringe with Spike Stellant CT Connector Tubing Stellant Dual Syringe Quad-Pak with Spikes Stellant Single Syringe with Spike and Japan "T" Connector Stellant Single Syringe Tri-Pak with Spike Stellant Low Pressure Connector Tubing with 14" "T" Connector and Prime Tube Stellant Single Syringe Tri-Pak with QFT Stellant Dual Quad-Pak with QFT Stellant 60" low pressure connector tubing with Prime Tube Stellant Dual Syringe Quad-Pak with a Large Saline Spke and a Small Contrast Spike Stellant Single Syringe with QFT Stellant CT Low Pressure Connector Tubing with T-Connector (SSS-LP-60-T) Low Pressure Connector Tube Set 60" w/ Prime Tube (SSS-LP-60) Low Pressure Connector Tube Set w/ T-connector (Japan) 60" (SJS-LP-60-T-J) Low Pressure Connector Tube Set w/ T-connector 60" (SSS-LP-60-T) Stellant CT 96" Low Pressure Connector Tubing (LP-96-T-CV) SDS-TRF-CV

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)