BEUDAMED
    FDA Registration Active 🇺🇸 United States

    5624-14/21XL

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    3

    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
    K072578

    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
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF

    Proprietary Names

    5624-14/21XL 5413-20/5 5213-58 5331-56/21 5413-20/5-10 5537-6/11 5331-46/17 5331-58/22 5624-6/15L 5213-44 5537-10/12 5624-12/13 5624-8/20XL 5213-56 5624-14/13 5624-12/21XL 5213-42 5331-42/15 5331-48/18 5213-50 5624-10/12 5537-12/13 5213-46 5413-20/5-20 5624-10/20XL 5213-48 5624-6/19XL 5331-50/18 5213-54 5624-10/16L 5624-8/16L 5213-52 5331-52/19 5331-44/16 5537-14/13 5413-20/6REV 5331-54/20 5624-14/17L 5537-8/12 5624-12/17L 5624-6/11 5331-40/15 5624-8/12

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)