BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stellant Dual Quad-Pak with QFT

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1058584
    FEI Number
    1000219637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10811 Withers Cove Park Drive
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023183

    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 Dual Quad-Pak with QFT Stellant Single Syringe Tri-Pak with QFT (Apollo) SSS-CTP-QFT Stellant Single Syringe with Spike (Enhanced) SSS-SPK Stellant Single Syringe Tri-Pak with Spike (Apollo) SSS-CTP-SPK Stellant Single Syringe with Spike and Japan "T" Connector LP-96-T-CV Low Pressure Connector Tube with T-Connector and Integral Check Valve Stellant Single Syringe with QFT Stellant Dual Syringe Quad-Pak with a Large Saline Spke and a Small Contrast Spike Stellant Single Syringe with Spike Stellant Single Syringe Tri-Pak with QFT Stellant Single Syringe Tri-Pak with Spike Stellant Dual Syringe Quad-Pak with QFT (Apollo) SDS-CTP-QFT Stellant Dual Syringe Quad-Pak with Spikes Stellant Single Syringe with QFT (Enhanced) SSS-QFT SSS-LP-60-T Low Pressure Connector Tube Set w/ T-connector 60" Stellant Dual Syringe Quad-Pak with Spike (Apollo) SDS-CTP-SPK Stellant CT Syringe Kits SJS-PT-J Stellant CT Syringe Kits (SJS-PT-J) Stellant CT 96" Low Pressure Connector Tubing (LP-96-T-CV)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)