BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rapid-Seal

    Reg #: 3016844359 · FEI: 3016844359 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MEDCURA, INC. (FKA GEL-E, INC.)
    Registration Number
    3016844359
    FEI Number
    3016844359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5650 Rivertech Ct., Ste S
    City
    Riverdale
    State
    MD
    ZIP
    20737
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192667

    Owner / Operator

    Firm Name
    Medcura, Inc. (FKA gel-e, Inc.)
    Operator Number
    10078977
    Address
    5650 Rivertech Ct., Ste S
    City
    Riverdale
    State
    MD
    Postal Code
    20737
    Country
    US
    Correspondent
    Matthew Dowling

    Products

    Device Name Product Code
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY

    Proprietary Names

    Rapid-Seal gel-e Flex+ gel OTC CutCure

    Establishment Types

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