BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device

    Reg #: 2648650 · FEI: 2648650 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ETHICON, LLC.
    Registration Number
    2648650
    FEI Number
    2648650
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Highway 183 Km. 8.3
    City
    San Lorenzo
    State
    PR
    ZIP
    00754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192580

    Owner / Operator

    Firm Name
    ETHICON INC.
    Operator Number
    2210968
    Address
    1000 US Highway 202 S.
    City
    Raritan
    State
    NJ
    Postal Code
    08869
    Country
    US
    Correspondent
    Reynaldo Librojo

    Products

    Device Name Product Code
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device

    Establishment Types

    Manufacture Medical Device