BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PALACOS R pro

    Reg #: 3013186738 · FEI: 3013186738 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Heraeus Medical LLC
    Registration Number
    3013186738
    FEI Number
    3013186738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    Township Line Road 770, Suite 300
    City
    Yardley
    State
    PA
    ZIP
    19067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150119

    Owner / Operator

    Firm Name
    Heraeus Medical GmbH
    Operator Number
    10048423
    Address
    Philipp-Reis-Str. 8/13
    City
    Wehrheim
    State
    Hesse
    Postal Code
    61273
    Country
    DE
    Correspondent
    Benjamin Hagedorn

    Products

    Device Name Product Code
    Dispenser, Cement KIH
    Mixer, Cement, For Clinical Use JDZ
    Bone Cement LOD

    Proprietary Names

    PALACOS R pro

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198