BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Burnfree SD

    Reg #: 3024971708 · FEI: 3024971708 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Carowinds
    Registration Number
    3024971708
    FEI Number
    3024971708
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ste A 13327 Carowinds Blvd
    City
    Charlotte
    State
    NC
    ZIP
    28273
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003396

    Owner / Operator

    Firm Name
    Productiv, Inc
    Operator Number
    10086303
    Address
    Ste A 13327 Carowinds Blvd
    City
    Charlotte
    State
    NC
    Postal Code
    28273
    Country
    US
    Correspondent
    Marius Ailenei

    Products

    Device Name Product Code
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ

    Proprietary Names

    Burnfree SD Cool Jel Unit Dose Prostat Burn Stop WJ Burn Stop

    Establishment Types

    Repack or Relabel Medical Device