BEUDAMED
    Product Code: SIL FDA unclassified

    Wound Dressings Containing Oxygen

    Unknown
    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    SIL
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A wound dressing containing oxygen is intended to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound.

    Unclassified Reason

    1