BEUDAMED
    Product Code: PHT FDA class 1 21 CFR 876.1500

    Basin For Endoscope Reprocessing

    Gastroenterology, Urology

    The Basin for Endoscope Reprocessing is a simple medical device designed to hold endoscopes and allow them to soak in reprocessing solutions as part of the disinfection and sterilization workflow. It is an FDA Class 1 device regulated under 21 CFR 876.1500, subject to general controls, within the Gastroenterology and Urology (GU) medical specialty. The product code is PHT. This device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PHT
    Device Class
    FDA class 1
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    Definition

    To allow endoscopes to soak in reprocessing solutions.

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.