BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    OTC - VACURECT Vacuum Constriction Device (RE: K020969)

    Reg #: 3003865243 · FEI: 3003865243 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BON ROUX (PTY) LTD
    Registration Number
    3003865243
    FEI Number
    3003865243
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    695 TETRA AVENUE, MORELETAPARK
    City
    PRETORIA Gauteng
    Country
    ZA

    Owner / Operator

    Firm Name
    BON ROUX (PTY) LTD
    Operator Number
    9050392
    Address
    695 TETRA AVENUE, --
    City
    MORELETAPARK PRETORIA
    State
    ZA-NOTA
    Postal Code
    0044
    Country
    ZA

    US Agent

    Business Name
    Mainspring Medical LLC
    Contact Name
    Donald Lechner
    Address
    205 New Petersburg Dr, Ste B
    City
    Martinez
    State
    GA
    ZIP
    30907
    Country
    US
    Email
    [email protected]
    Phone
    706 4264145 ext. 0

    Products

    Device Name Product Code
    Device, External Penile Rigidity LKY

    Proprietary Names

    OTC - VACURECT Vacuum Constriction Device (RE: K020969) RX - VACURECT Vacuum Constriction Device (RE: K032776)

    Establishment Types

    Manufacture Medical Device