BEUDAMED
    Product Code: NMP FDA class 2 21 CFR 892.5730

    Needle, Isotope, Reprocessed

    Radiology

    The isotope needle (reprocessed) is a radiology device used to deliver or position radioactive isotopes for diagnostic or therapeutic nuclear medicine procedures. It is classified as FDA Class 2 under regulation 892.5730 in the Radiology specialty, requiring 510(k) premarket notification. As a reprocessed device under product code NMP, reprocessing validation data must be included in the 510(k) submission. This device is not eligible for third-party review.

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

    Product Code
    NMP
    Device Class
    FDA class 2
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

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

    Definition

    Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).