BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Raphael 25L

    Reg #: 3038185071 · FEI: 3038185071 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OTS-MEDICAL
    Registration Number
    3038185071
    FEI Number
    3038185071
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Alon Yegal 94
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K241234

    Owner / Operator

    Firm Name
    OTS-Medical
    Operator Number
    10093227
    Address
    Alon Yegal 94
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6789139
    Country
    IL
    Correspondent
    Adely Levy

    US Agent

    Business Name
    Kawchak Ortho Supply LLC
    Contact Name
    Christopher Kawchak
    Address
    1929 E Moor Mont Dr
    City
    Salt Lake City
    State
    UT
    ZIP
    84117
    Country
    US
    Email
    [email protected]
    Phone
    814 2335552

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Raphael 25L

    Establishment Types

    Manufacture Medical Device