BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STAT Super-Fine Insulin Pen Needle Standard

    Reg #: 1058955 · FEI: 1000525253 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STAT MEDICAL DEVICES, INC.
    Registration Number
    1058955
    FEI Number
    1000525253
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2056 NE 153rd St
    City
    North Miami Beach
    State
    FL
    ZIP
    33162
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092016

    Owner / Operator

    Firm Name
    STAT MEDICAL DEVICES, INC.
    Operator Number
    9020044
    Address
    2056 NE 153rd Street, --
    City
    North Miami Beach
    State
    FL
    Postal Code
    33162
    Country
    US

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    STAT Super-Fine Insulin Pen Needle Standard STAT Super-Fine Insulin Pen Needle Xtra STAT Super-Fine Insulin Pen Needle Micro

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility