BEUDAMED
    FDA Registration Active 🇺🇸 United States

    254.38S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    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
    K914453

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    254.38S 254.25S 250.25S 253.38S 278.36S 458.78S 458.74S 252.30S 279.38S 252.33S 252.42S 254.30S 251.28S 254.27S 278.38S 458.72S 253.28S 252.27S 254.42S 252.34S 250.42S 252.25S 458.66S 253.27S 253.36S 254.28S 279.42S 250.27S 279.30S 252.28S 254.40S 252.36S 251.27S 458.80S 279.31S 250.40S 254.31S 279.40S 279.28S 251.36S 251.40S 253.33S 253.40S 252.40S 278.25S 279.34S 251.31S 251.33S 278.34S 458.68S 279.36S 254.33S 250.30S 253.25S 458.70S 278.33S 278.40S 250.36S 250.31S 250.34S 251.38S 251.34S 278.30S 253.31S 254.36S 250.28S 253.42S 253.34S 278.27S 254.34S 278.31S 252.31S 279.25S 251.42S 252.38S 250.33S 251.25S 253.30S 250.38S 458.76S 251.30S 278.42S 279.27S 278.28S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)