BEUDAMED
    Product Code: MTZ FDA class 2 21 CFR 886.3320

    Wrap, Implant, Orbital

    Ophthalmic

    An Orbital Implant Wrap is a thin sheet material placed around an orbital implant (used to fill the eye socket following enucleation or evisceration) to promote tissue integration and secure the implant within the orbit. It is FDA Class 2, requiring 510(k) clearance, classified as an implant, with product code MTZ under 21 CFR 886.3320 in the Ophthalmic specialty. The device is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    5

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    Basic Information

    Product Code
    MTZ
    Device Class
    FDA class 2
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K023643 MACROPORE SURGICAL BARRIER FILM
    K973552 OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP