BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SpineSeal Spine Sealant

    Reg #: 3016980830 · FEI: 3016980830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PRAMAND LLC
    Registration Number
    3016980830
    FEI Number
    3016980830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    201 Burlington Road, Suite 210, North Building
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    PMA Number
    P240027

    Owner / Operator

    Firm Name
    Pramand LLC
    Operator Number
    10078839
    Address
    201 Burlington Road, Suite 210, North Building
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Daniel F Phelan

    Products

    Device Name Product Code
    Sealant, Dural NQR

    Proprietary Names

    SpineSeal Spine Sealant

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility