BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Golnit PTFE Sutures

    Reg #: 3014117096 · FEI: 3014117096 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ANTARMA LLC
    Registration Number
    3014117096
    FEI Number
    3014117096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    276 5th Ave Rm 704
    City
    New York
    State
    NY
    ZIP
    10001
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163049

    Owner / Operator

    Firm Name
    Antarma LLC dba Golnit Sutures
    Operator Number
    10056317
    Address
    276 5th Ave Rm 704
    City
    New York
    State
    NY
    Postal Code
    10001
    Country
    US
    Correspondent
    Armine Badalyan

    Products

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

    Proprietary Names

    Golnit PTFE Sutures

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility