BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gredale Level 3 USA-Made Surgical Gown

    Reg #: 3016711507 · FEI: 3016711507 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GREDALE, LLC
    Registration Number
    3016711507
    FEI Number
    3016711507
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1735 S Santa Fe Avenue
    City
    Los Angeles
    State
    CA
    ZIP
    90021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111067

    Owner / Operator

    Firm Name
    Gredale, LLC
    Operator Number
    10065040
    Address
    1735 S Santa Fe Avenue
    City
    Los Angeles
    State
    CA
    Postal Code
    90021
    Country
    US

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    Gredale Level 3 USA-Made Surgical Gown Gredale Level 4 USA-Made Surgical Gown

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)