BEUDAMED
    FDA Registration Active 🇺🇸 United States

    485.130S

    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
    K962047

    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

    485.130S 459.34S 485.127S 485.125S 459.32S 485.331S 485.240S 485.327S 485.325S 459.60S 485.140S 485.333S 459.36S 459.56S 485.131S 459.90S 485.133S 485.234S 459.80S 48525S 485.242S 485.236S 48534S 485.233S 485.128S 485.238S 459.30S 485.227S 48536S 459.52S 485.338S 485.225S 48540S 485.340S 459.26S 485.330S 48542S 459.42S 48527S 459.50S 485.231S 485.136S 459.76S 459.48S 485.134S 459.28S 48533S 48538S 48531S 485.328S 459.68S 459.64S 485.342S 459.95S 48528S 459.54S 458.110S 458.120S 485.336S 459.72S 459.85S 485.138S 48530S 459.40S 485.230S 459.38S 485.142S 459.46S 485.334S 485.228S 459.58S 459.100S 459.44S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)