BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FOLLISTIM Pen & Needle Starter Kit; FOLLISTIM Cartridge & Needles

    Reg #: 1036761 · FEI: 1036761 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Merck Sharp & Dohme LLC
    Registration Number
    1036761
    FEI Number
    1036761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4633 Merck Road
    City
    Wilson
    State
    NC
    ZIP
    27893
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162516

    Owner / Operator

    Firm Name
    Merck Sharp & Dohme LLC
    Operator Number
    2211109
    Address
    351 North Sumneytown Pike
    City
    North Wales
    State
    PA
    Postal Code
    19454
    Country
    US
    Correspondent
    Zain A Zia

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    FOLLISTIM Pen & Needle Starter Kit; FOLLISTIM Cartridge & Needles

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)