BEUDAMED
    Product Code: NOI FDA class 1 21 CFR 886.1860

    Stand, Instrument, Ophthalmic, Battery Powered

    Ophthalmic

    The battery-powered ophthalmic instrument stand is an ophthalmic accessory device designed to store and hold ophthalmic instruments in a readily accessible position during clinical use. It is classified as FDA Class 1 under regulation 886.1860 in the Ophthalmic specialty, and it is GMP exempt. Product code NOI does not require a 510(k) submission and represents a battery-powered version of standard ophthalmic instrument stands.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NOI
    Device Class
    FDA class 1
    Regulation Number
    886.1860
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    Definition

    AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.