BEUDAMED
    FDA Registration Active 🇺🇸 United States

    90054 10 FR Foley TempT 400 series Thermistor

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721686
    FEI Number
    1721686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2400 Airport Rd
    City
    Santa Teresa
    State
    NM
    ZIP
    88008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K831567

    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
    Catheter, Urological KOD

    Proprietary Names

    90054 10 FR Foley TempT 400 series Thermistor 90051 16 FR Foley TempT 400 series Thermistor 90053 8 FR Foley TempT 400 series Thermistor 90056 14 FR Foley TempT 400 series Thermistor 90052 18 FR Foley TempT 400 series Thermistor 90055 12 FR Foley TempT 400 series Thermistor

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)