BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HyperSuture

    Reg #: 3017499940 · FEI: 3017499940 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    THREADSTONE LLC
    Registration Number
    3017499940
    FEI Number
    3017499940
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1035 Benfield Blvd Ste H
    City
    Millersville
    State
    MD
    ZIP
    21108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234079

    Owner / Operator

    Firm Name
    Threadstone LLC
    Operator Number
    10078443
    Address
    1035 Benfield blvd, suite H
    City
    Millersville
    State
    MD
    Postal Code
    21108
    Country
    US
    Correspondent
    jeremy clark

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    HyperSuture

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198