BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DANNIK

    Reg #: 3015775837 · FEI: 3015775837 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    DANNIK
    Registration Number
    3015775837
    FEI Number
    3015775837
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3201 East Colonial Drive, Suite M3
    City
    Orlando
    State
    FL
    ZIP
    32803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211019

    Owner / Operator

    Firm Name
    DANNIK
    Operator Number
    10061208
    Address
    941 W Morse Blvd., Suite 100
    City
    Winter Park
    State
    FL
    Postal Code
    32789
    Country
    US
    Correspondent
    Olga Haberland

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Laparoscope, General & Plastic Surgery GCJ
    Cannula, Surgical, General & Plastic Surgery GEA

    Proprietary Names

    Disposable Monopolar Laparoscopic Tips and Reusable Handles Dannik Poly Specimen Retrieval System Dannik Specimen Retrieval Systems DANNIK Disposable Monopolar Instruments Trocar Cannula System Trocar Cannula System II

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device