BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Braid Suture

    Reg #: 3007319107 · FEI: 3007319107 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PARCUS MEDICAL , L.L.C.
    Registration Number
    3007319107
    FEI Number
    3007319107
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6423 Parkland Dr
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202242

    Owner / Operator

    Firm Name
    Medacta International SA
    Operator Number
    10024526
    Address
    Strada Regina
    City
    Castel San Pietro
    State
    Ticino
    Postal Code
    6874
    Country
    CH
    Correspondent
    Stefano Baj

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    Braid Suture

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198