BEUDAMED
    Product Code: IWW FDA class 1 21 CFR 892.6500

    Shield, Vial

    Radiology

    A vial shield is a lead or radiation-attenuating container used to hold and transport vials containing radioactive materials in nuclear medicine settings, protecting personnel from radiation exposure during preparation and handling of radiopharmaceuticals. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWW, regulated under 21 CFR 892.6500, within the Radiology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IWW
    Device Class
    FDA class 1
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K934548 ALL-VUE & GAMMA-VUE VIAL SHIELDS

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.