BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RING SIM 700FF33 FULLY FLEXIBLE

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K052565

    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
    Ring, Annuloplasty KRH

    Proprietary Names

    RING SIM 700FF33 FULLY FLEXIBLE RING SIM 700FF23 FULLY FLEXIBLE RING SIM 700FF25 FULLY FLEXIBLE RING SIM 700FF35 FULLY FLEXIBLE RING SIM 700FF37 FULLY FLEXIBLE RING SIM 700FF27 FULLY FLEXIBLE RING SIM 700FF39 FULLY FLEXIBLE BAND SIM 725FC25 FULL FLEXIBLE RING SIMULUS FULLY FLEXIBLE (700FFXX PRODUCT FAMILY) 700FF31 700FF25 700FF35 700FF27 700FF23 700FF33 700FF37 700FF29 700FF39 RING SIM 700FF29 FULLY FLEXIBLE RING SIM 700FF31 FULLY FLEXIBLE

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)