BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Genesys Matryx

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    1054811
    FEI Number
    1000114185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    502 Prairie Mine Rd
    City
    MULBERRY
    State
    FL
    ZIP
    33860
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102410

    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

    Genesys Matryx GENESYS Matryx™ 8mm x 25mm GENESYS Matryx™ 5mm x 30mm GENESYS Matryx™ 5.5mm x 30mm GENESYS Matryx™ 10mm x 30mm GENESYS Matryx™ 8mm x 20mm GENESYS Matryx™ 9mm x 25mm GENESYS Matryx™ 5mm x 15mm GENESYS Matryx™ 5.5mm x 25mm GENESYS Matryx™ 11mm x 30mm GENESYS Matryx™ 6.5mm x 15mm GENESYS Matryx™ 9mm x 30mm GENESYS Matryx™ 6.5mm x 20mm GENESYS Matryx™ 11mm x 40mm GENESYS Matryx™ 11mm x 35mm GENESYS Matryx™ 9mm x 20mm GENESYS Matryx™ 11mm x 20mm GENESYS Matryx™ 10mm x 35mm GENESYS Matryx™ 10mm x 25mm GENESYS Matryx™ 8mm x 30mm GENESYS Matryx™ 5mm x 20mm GENESYS Matryx™ 7mm x 20mm GENESYS Matryx™ 8mm x 35mm GENESYS Matryx™ 6.5mm x 25mm GENESYS Matryx™ 6mm x 25mm GENESYS Matryx™ 6mm x 20mm GENESYS Matryx™ 5.5mm x 15mm GENESYS Matryx™ 6mm x 30mm GENESYS Matryx™ 6mm x 15mm GENESYS Matryx™ 9mm x 35mm GENESYS Matryx™ 7mm x 30mm GENESYS Matryx™ 5.5mm x 20mm GENESYS Matryx™ 11mm x 25mm GENESYS Matryx™ 6.5mm x 30mm GENESYS Matryx™ 5mm x 25mm GENESYS Matryx™ 7mm x 25mm GENESYS Matryx™ 10mm x 20mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)