BEUDAMED
    Product Code: PZG FDA class 1 21 CFR 886.4350

    Surgical Eye Tray

    Ophthalmic

    The Surgical Eye Tray is a convenience kit packaging the instruments and materials needed for ophthalmic surgical procedures, used in eye surgery settings. It is classified as a Class 1 device under regulation 886.4350, subject to general controls only, and per the FDA's May 1997 convenience kits guidance, it is under enforcement discretion and does not require a 510(k) premarket notification if all criteria in the guidance are met. The product code is PZG, and it falls within the Ophthalmic (OP) medical specialty. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    29
    Registration Numbers
    30
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PZG
    Device Class
    FDA class 1
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    7

    Device Characteristics

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

    Definition

    This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.