BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEN- 13820, Calcium Alginate Ag (Silver) 8" x 8" Dressing

    Reg #: 2530957 · FEI: 1000522686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENTELL
    Registration Number
    2530957
    FEI Number
    1000522686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    180 Rittenhouse Circle
    City
    Bristol
    State
    PA
    ZIP
    19007
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120181

    Owner / Operator

    Firm Name
    GENTELL
    Operator Number
    10026501
    Address
    180 Rittenhouse Circle,
    City
    Bristol
    State
    PA
    Postal Code
    19007
    Country
    US
    Correspondent
    Michael Alford

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    GEN- 13820, Calcium Alginate Ag (Silver) 8" x 8" Dressing GEN- 13220, Calcium Alginate Ag (Silver) 2" x 2" Dressing GEN- 13420, Calcium Alginate Ag (Silver) 4" x 4" Dressing GEN- 13620, Calcium Alginate Ag (Silver) 6" x 6" Dressing GEN- 13482, Calcium Alginate Ag (Silver) 4" x 8" Dressing GEN-13142, Calcium Alginate Ag(Silver)12 inch Rope Dressing

    Establishment Types

    Manufacture Medical Device