BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    eFilm Lite

    DI: 00842000100300 · Model: 4.2.1 · MERGE HEALTHCARE SOLUTIONS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    eFilm Lite
    Primary DI
    00842000100300
    Version / Model
    4.2.1
    Company Name
    MERGE HEALTHCARE SOLUTIONS INC.
    Labeler DUNS
    065626069
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-31
    Public Version
    6
    Public Version Date
    2023-12-15
    Public Version Status
    Update
    Public Device Record Key
    01c9643c-8429-42c6-89f5-e26fb79b9de6
    Distribution End Date
    2022-06-30

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 00842000100300