BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PrevahexCHX 1485CH

    Reg #: 3009134884 · FEI: 3011393407 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ENTROTECH LIFE SCIENCES, LLC
    Registration Number
    3009134884
    FEI Number
    3011393407
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1245 Kinnear Road
    City
    Columbus
    State
    OH
    ZIP
    43212
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140389

    Owner / Operator

    Firm Name
    entrotech life sciences, llc
    Operator Number
    10088716
    Address
    1245 Kinnear Road
    City
    Columbus
    State
    OH
    Postal Code
    43212
    Country
    US
    Correspondent
    George J Holinga

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    PrevahexCHX 1485CH PrevahexCHX 1492CH PrevahexCHX 1484CH PrevahexCHX 1483CH PrevahexCHX 1491CH

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device