BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENDOTINE MIDFACE-ST

    Reg #: 1036836 · FEI: 1036836 · 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
    1036836
    FEI Number
    1036836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1148 Porter Ave
    City
    Haw River
    State
    NC
    ZIP
    27258
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060249

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    ENDOTINE MIDFACE-ST ENDOTINE MIDFACE B MBA Titanium Subtalar Implant System ENDOTINE TRANSBLEPH MBA Subtalar Implant System ENDOTINE FOREHEAD Kompressor Compression Screw System Integra Kompressor Compression Screw System ENDOTINE TRIPLE

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)