BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spectris MR Qwik-Fit Syringe

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    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
    K980417

    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
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Spectris MR Qwik-Fit Syringe Spectris MR Kit with Integral "T" Female to Female Adapter Female-to-Female Luer Adapter (FFA-50) Spectris MR Kit with Integral "T" (SIT 96V) Disposable MRI Kit with Check Valve (SQK 65VS) Disposable MRI Kit with Check Valve (SQK-65VA) Disposable MRI Tubing Set (SIT-96V)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)