BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultracell ® Epistaxis slim Pack 8 cm with String

    Reg #: 1211998 · FEI: 1211998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beaver-Visitec International, Inc.
    Registration Number
    1211998
    FEI Number
    1211998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    303 Wyman St Ste 350
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K924542

    Owner / Operator

    Firm Name
    Beaver-Visitec International, Inc.
    Operator Number
    10033379
    Address
    500 Totten Pond Rd, 10 CityPoint
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Balloon, Epistaxis EMX

    Proprietary Names

    Ultracell ® Epistaxis slim Pack 8 cm with String Ultracell® 10 cm Epistaxis Pack with String Ultracell® 10 cm Epistaxis Pack with String, Layered Ultracell ® Epistaxis Pack 5.5 cm with String Ultracell® Sinus Pack 3.5 cm with String Ultracell® Sinus Pack Ultra Slim 3.5 cm with String Ultracell ® Sinus Pack Ultra Slim 2.5 cm with String Ultracell ® Anterior Epistaxis Pack 3 cm with String Ultracell ® Epistaxis Pack with String (3 cm) Ultracell® Sinus Pack Slim 3.5 cm with String

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility