BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SILVRSTAT® Antibacterial Wound Dressing Gel

    Reg #: 3008396914 · FEI: 3008396914 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABL Manufacturing, LLC
    Registration Number
    3008396914
    FEI Number
    3008396914
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1306 South 630 East
    City
    American Fork
    State
    UT
    ZIP
    84003
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092826

    Owner / Operator

    Firm Name
    ABL Manufacturing, LLC
    Operator Number
    10033426
    Address
    ABL Manufacturing, LLC, 1306 south 630 east
    City
    Am Fork
    State
    UT
    Postal Code
    84003
    Country
    US
    Correspondent
    Nathan Moeller

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    SILVRSTAT® Antibacterial Wound Dressing Gel Silver SG Wound Dressing Gel Dermasyn/AG Wound Dressing Gel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)