BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Comaneci 17

    Reg #: 3015531723 · FEI: 3015531723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RAPID MEDICAL INC.
    Registration Number
    3015531723
    FEI Number
    3015531723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    445 South Kimball Avenue, Suite 140
    City
    Southlake
    State
    TX
    ZIP
    76092
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN170064

    Owner / Operator

    Firm Name
    Rapid Medical Inc.
    Operator Number
    10060780
    Address
    445 South Kimball Avenue, Suite 140
    City
    Southlake
    State
    TX
    Postal Code
    76092
    Country
    US
    Correspondent
    Ina Gutman

    Products

    Device Name Product Code
    Temporary Coil Embolization Assist Device PUU

    Proprietary Names

    Comaneci 17 Comaneci Comaneci Petit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198