BEUDAMED
    Product Code: OHW FDA class 1 21 CFR 886.4070

    Burr, Corneal, Battery Powered, Rust Ring Removal

    Ophthalmic

    The Battery Powered Corneal Burr for Rust Ring Removal is a battery-powered motor and drilling tool used by ophthalmic clinicians to remove metallic rust rings from the cornea of the eye following a foreign body injury. Classified as FDA Class 1 under regulation 21 CFR 886.4070 within the Ophthalmic medical specialty, it is subject to general controls only and is exempt from the 510(k) premarket notification requirement when intended solely for rust ring removal. The product code is OHW. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OHW
    Device Class
    FDA class 1
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    Definition

    A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.