BEUDAMED
    FDA Registration Active 🇺🇸 United States

    08.843.710S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    73
    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
    K120275

    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
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    08.843.710S 08.843.205S 08.843.210S 08.84312S 08.843.411S 08.843.607S 08.843.105S 08.843.610S 08.843.611S 08.843.104S 08.843.705S 08.843.310S 08.843.305S 08.843.408S 08.843.812S 08.843.808S 08.843.709S 08.843.308S 08.843.708S 08.843.409S 08.843.106S 08.843.108S 08.843.511S 08.843.512S 08.843.206S 08.84307S 08.843.406S 08.843.609S 08.843.212S 08.843.208S 08.843.410S 08.843.505S 08.843.312S 08.84311S 08.843.506S 08.843.510S 08.843.711S 08.84309S 08.843.107S 08.843.509S 08.843.712S 08.843.608S 08.843.209S 08.843.810S 08.84306S 08.84308S 08.843.110S 08.843.112S 08.843.111S 08.843.211S 08.843.807S 08.843.707S 08.84305S 08.843.605S 08.843.811S 08.843.508S 08.843.405S 08.843.407S 08.843.507S 08.843.806S 08.843.207S 08.843.412S 08.843.109S 08.843.306S 08.843.809S 08.84310S 08.843.612S 08.843.805S 08.843.706S 08.843.309S 08.843.606S 08.843.307S 08.843.311S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)