BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Two Part Modified Cournand Needle

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K800122

    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
    Instruments, Surgical, Cardiovascular DWS

    Proprietary Names

    Two Part Modified Cournand Needle Guide Wire Introducer Needle Two Part Seldinger Access Needle APU525 APU550 APU552 APU544 APU556 APU430 APU444 APU530 APU425 APU548 APU450 APU452 APU440 APU456 APU435 APU448 APU560 APU535 APU540 APU460

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)