BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MI DeTACH Aortic Cross Clamp Delivery Device

    Reg #: 3005593675 · FEI: 3005593675 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOREP TECHNOLOGIES, INC.
    Registration Number
    3005593675
    FEI Number
    3005593675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15804 NW 57th Ave
    City
    Miami Lakes
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210006

    Owner / Operator

    Firm Name
    Biorep Technologies, Inc.
    Operator Number
    10035038
    Address
    15804 NW 57th Ave
    City
    Miami Lakes
    State
    FL
    Postal Code
    33014
    Country
    US
    Correspondent
    Victoria M Enjamio

    Products

    Device Name Product Code
    Clamp, Vascular DXC

    Proprietary Names

    MI DeTACH Aortic Cross Clamp Delivery Device MI DeTACH Aortic Cross Clamp Delivery System Kit MI DeTACH Aortic Cross Clamp Head Small MI DeTACH Aortic Cross Clamp Head Medium MI DeTACH Aortic Cross Clamp Quick Release MI DeTACH Aortic Cross Clamp Head Large

    Establishment Types

    Manufacture Medical Device