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    FDA UDI In Commercial Distribution 🇺🇸 United States

    APELEM

    DI: 03760172650003 · Model: PLATINUM dRF · APELEM
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APELEM
    Primary DI
    03760172650003
    Version / Model
    PLATINUM dRF
    Company Name
    APELEM
    Labeler DUNS
    268596533
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-23
    Public Version
    4
    Public Version Date
    2023-06-08
    Public Version Status
    Update
    Public Device Record Key
    787f63ec-9fa0-4c72-a2f1-b035c7ca498b

    Device Description

    Remote controlled radiology system

    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
    No
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    40655 Basic diagnostic x-ray system table, powered

    Identifiers

    Type ID
    Primary 03760172650003