BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SuperBall-RC 12 degree inserter

    Reg #: 3016926753 · FEI: 3016926753 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ARCURO MEDICAL LTD.
    Registration Number
    3016926753
    FEI Number
    3016926753
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 Tchelet St., Misgav Business Park
    City
    Misgav Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K244015

    Owner / Operator

    Firm Name
    Arcuro Medical Ltd.
    Operator Number
    10074120
    Address
    17 Tchelet St., Misgav Business Park
    City
    Misgav
    State
    IL-NOTA
    Postal Code
    2017400
    Country
    IL
    Correspondent
    Dan Shlezak

    US Agent

    Business Name
    Arcuro Medical Inc.
    Contact Name
    Philip Hamann
    Address
    4850 Tamiami Trail North, Suite 301
    City
    Naples
    State
    FL
    ZIP
    34103
    Country
    US
    Email
    [email protected]
    Phone
    239 8601068

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    SuperBall-RC 12 degree inserter

    Establishment Types

    Manufacture Medical Device