BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dukal Sterilization Pouch

    Reg #: 2435946 · FEI: 1000137528 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    DUKAL LLC
    Registration Number
    2435946
    FEI Number
    1000137528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2 Fleetwood Ct.
    City
    Ronkonkoma
    State
    NY
    ZIP
    11779
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162258

    Owner / Operator

    Firm Name
    DUKAL LLC
    Operator Number
    9005925
    Address
    2 Fleetwood Ct, --
    City
    Ronkonkoma
    State
    NY
    Postal Code
    11779
    Country
    US
    Correspondent
    Kara - Mckigney

    Products

    Device Name Product Code
    Indicator, Physical/Chemical Sterilization Process JOJ
    Wrap, Sterilization FRG

    Proprietary Names

    Dukal Sterilization Pouch

    Establishment Types

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