BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device

    Reg #: 3007791599 · FEI: 3007791599 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ETHICON, LLC
    Registration Number
    3007791599
    FEI Number
    3007791599
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    475 C Street, Los Frailes Industrial Park, Suite 401
    City
    Guaynabo
    State
    PR
    ZIP
    00969
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182873

    Owner / Operator

    Firm Name
    ETHICON, LLC
    Operator Number
    10029715
    Address
    475 C Street, Los Frailes Industrial Park, Suite 401
    City
    Guaynabo
    State
    PR
    Postal Code
    00969
    Country
    US
    Correspondent
    Reynaldo Librojo

    Products

    Device Name Product Code
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Surgical, Absorbable, Polydioxanone NEW

    Proprietary Names

    STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

    Establishment Types

    Manufacture Medical Device