BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PA1025

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K000904

    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
    Apparatus, Exhaust, Surgical FYD

    Proprietary Names

    PA1025 VT10206 USGPA1025 SSHA-91 VTWT505 VTESU05 ARWLR1410 VTWT805 VTWT206 PA2010CB MQVTWT424 PP010 PA2010BS USGVT10424 VT38S1010 MQPA1025 MQVTESU05 VTWTS10 MQBLAP100V VTWT515 BAPA2010B BLAP100 ARRF10210 VTWT624 SSHA-85 BLAP100V PA2010 MH100003 VTWT406 VTWTC05 ARVT10424 VT10624 PA2010B BESIWT110 VT10405 VTWT424 LAPEVAC MQPA2010 ARVTVIC05-2 ARVTWT424 PA1025A MQVTWT624 MQPA2010B VTVIC10 ARBLAP100V MH100004 MQVTVIC10 PS1025CB VT10424 WLRT410 MQWLRT410 RF10210 BLAPC05 USGBLAP100V

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)