BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WIZARD² Gamma Counter

    DI: 00812589020535 · Model: 3470-0150 · REVVITY SINGAPORE PTE. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WIZARD² Gamma Counter
    Primary DI
    00812589020535
    Version / Model
    3470-0150
    Catalog Number
    3470-0150
    Company Name
    REVVITY SINGAPORE PTE. LTD.
    Labeler DUNS
    894632777
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-14
    Public Version
    3
    Public Version Date
    2023-06-22
    Public Version Status
    Update
    Public Device Record Key
    eca291e0-b53c-4ff7-9185-8d0698f07d5f

    Device Description

    An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJJ Counter (Beta, Gamma) For Clinical Use

    GMDN Terms

    Code Name
    56721 Radioimmunoassay analyser IVD, automated/semi-automated

    Identifiers

    Type ID
    Primary 00812589020535

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 35 Degrees Celsius