BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pinn Multihole w/Gription 64mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    3

    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
    K093646

    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    Pinn Multihole w/Gription 64mm Pinn Multihole w/Gription 58mm Pinn Sector w/Gription 60mm Pinn Sector w/Gription 54mm Pinn Sector w/Gription 58mm Pinn Multihole w/Gription 62mm Pinn Multihole w/Gription 54mm Pinn Multihole w/Gription 50mm Pinn Sector w/Gription 62mm Pinn Sector w/Gription 64mm Pinn Multihole w/Gription 66mm Pinn Sector w/Gription 50mm Pinn Sector w/Gription 52mm Pinn Multihole w/Gription 60mm Pinn Multihole w/Gription 52mm Pinn Multihole w/Gription 48mm PINNACLE REVISION W/GRIPTION PINNACLE DEEP REV W/GRIPTION PINN MULTIHOLE W/GRIPTION PINN SECTOR W/GRIPTION PINN BANTAM W/GRIPTION Pinn Sector w/Gription 48mm Pinn Sector w/Gription 66mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)