BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    SimPro™ Now, GentleCath™ Hydrophilic

    Reg #: 3021206558 · FEI: 3021206558 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GAMMA-PAK STERILIZASYON SANAYI VE TICARET ANONIM SIRKETI
    Registration Number
    3021206558
    FEI Number
    3021206558
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MASLAK MAH. TAS YONCASI SOK. MASLAK 1453 T BLOK NO:1 IC KAPI NO: B172
    City
    SARIYER Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K223756

    Owner / Operator

    Firm Name
    GAMMA-PAK STERILIZASYON SANAYI VE TICARET ANONIM SIRKETI
    Operator Number
    10083647
    Address
    MASLAK MAH. TAS YONCASI SOK. MASLAK 1453 T BLOK NO:1 IC KAPI NO: B172
    City
    SARIYER
    State
    Istanbul
    Postal Code
    34398
    Country
    TR

    US Agent

    Business Name
    LIBERTY MANAGEMENT GROUP LTD
    Contact Name
    Manoj Zacharias
    Address
    75 Executive Drive, Suite 114
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

    Device Name Product Code
    Catheter, Coude EZC
    Catheter, Straight EZD

    Proprietary Names

    SimPro™ Now, GentleCath™ Hydrophilic

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)