BEUDAMED
    FDA Registration Active 🇺🇸 United States

    310.35S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    56
    Establishment Types
    1
    Classifications
    4

    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
    K962913

    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
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Bur, Surgical, General & Plastic Surgery GFF
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Blade, Saw, General & Plastic Surgery, Surgical GFA

    Proprietary Names

    310.35S 310.20S 310.36S 310.44S 310.30S 310.60JS 310.27S 310.25S 315.35S 3964S 315.40S 315.28S 310.11S 310.26S 310.10S 310.37S 310.29S 310.19S 310.14S 3155S 310.111S 315.31S 310.143S 310.16JS 310.38S 310.141S 315.19S 310.21S 315.29S 310.24S 3965S 315.23S 3966S 310.16S 310.21JS 315.25S 310.28S 310.65S 315.37S 3969S 315.26S 310.32S 3102S 310.48S 310.63S 310.31S 3967S 310.45S 310.67S 310.28JS 310.60S 310.15S 3968S 315.21S 310.66S 310.23S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)