BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DuraStat

    Reg #: 3015489699 · FEI: 3015489699 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    DuraStat
    Registration Number
    3015489699
    FEI Number
    3015489699
    Status
    Active
    Expiry Year
    2026
    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
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Holder, Needle; Orthopedic HXK

    Proprietary Names

    DuraStat TissueStat

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device