BEUDAMED
    FDA Registration Active 🇺🇸 United States

    *(S) STRYKER HOOD REPLACEMENTS

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1061124
    FEI Number
    1000512168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10821 Withers Cove Park Dr
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K910515

    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
    Gown, Surgical FYA

    Proprietary Names

    *(S) STRYKER HOOD REPLACEMENTS (S) MARK III LENS/ HOOD COMBO 12/CS (S) FREEDOMAIRE LENS / HOOD STERILE, 12/CS (S) TOGA GOWN / IMPERMEABLE BARRIER 12/CS (S) TOGA GOWN, ZIPPERED, SONTARA 12/CS TOGA GOWN, ZIPPERED, XXL, FREEDOM AIRE W/FILTER TOGA GOWN, REG, ZIPPERED, FREEMDOM AIRE W/FILTER (S) ACS FACE SHIELD ONLY, STERILE Freedomaire surgical helmet system

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)