BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Jada System

    Reg #: 3017425145 · FEI: 3017425145 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Organon LLC
    Registration Number
    3017425145
    FEI Number
    3017425145
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 Hudson Street, Floor 33
    City
    Jersey City
    State
    NJ
    ZIP
    07302
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212757

    Owner / Operator

    Firm Name
    Organon LLC
    Operator Number
    10077872
    Address
    30 Hudson Street, Floor 33
    City
    Jersey City
    State
    NJ
    Postal Code
    07302
    Country
    US
    Correspondent
    Francisco Haro

    Products

    Device Name Product Code
    Intrauterine Tamponade Balloon OQY

    Proprietary Names

    Jada System

    Establishment Types

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