BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DuraStat

    Reg #: 3015489699 · FEI: 3015489699 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DuraStat
    Registration Number
    3015489699
    FEI Number
    3015489699
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1101 E 6th St, Unit B
    City
    Austin
    State
    TX
    ZIP
    78702
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173335

    Owner / Operator

    Firm Name
    DuraStat LLC
    Operator Number
    10059251
    Address
    1101 E 6th St, Unit B
    City
    Austin
    State
    TX
    Postal Code
    78702
    Country
    US

    Products

    Device Name Product Code
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY

    Proprietary Names

    DuraStat

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device