BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EndoTool IV System; EndoTool IV 2

    Reg #: 3009864844 · FEI: 3009864844 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Monarch Medical Technologies
    Registration Number
    3009864844
    FEI Number
    3009864844
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    112 S. Tryon Street, Suite 800
    City
    Charlotte
    State
    NC
    ZIP
    28284
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201619

    Owner / Operator

    Firm Name
    Monarch Medical Technologies
    Operator Number
    10042124
    Address
    112 South Tryon Street, Suite 800
    City
    Charlotte
    State
    NC
    Postal Code
    28284
    Country
    US

    Products

    Device Name Product Code
    Calculator, Drug Dose NDC

    Proprietary Names

    EndoTool IV System; EndoTool IV 2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device