BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    DURACON; DURACON PRESSFIT STEM COCR; EXETER INTRAMEDULLARY BONE PLUG; TI DURACON REG FLUTED STEM

    Reg #: 3005581234 · FEI: 3005581234 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nelipak Healthcare Packaging
    Registration Number
    3005581234
    FEI Number
    3005581234
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KILBEGGAN ROAD
    City
    CLARA, Offaly
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K032163

    Owner / Operator

    Firm Name
    Nelipak Healthcare Packaging
    Operator Number
    9082522
    Address
    KILBEGGAN ROAD, --
    City
    CLARA, CO.OFFALY
    State
    IE-NOTA
    Postal Code
    R35 F583
    Country
    IE
    Correspondent
    Sara - Cahill

    US Agent

    Business Name
    Nelipak Healthcare Packaging
    Contact Name
    Rolando Salas
    Address
    21 Amflex Drive
    City
    Cranston
    State
    RI
    ZIP
    02921
    Country
    US
    Email
    [email protected]
    Phone
    401 9462699

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH

    Proprietary Names

    DURACON; DURACON PRESSFIT STEM COCR; EXETER INTRAMEDULLARY BONE PLUG; TI DURACON REG FLUTED STEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)