BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Enlitic Curie

    DI: 00860002304526 · Model: 1.0.0 · Enlitic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Enlitic Curie
    Primary DI
    00860002304526
    Version / Model
    1.0.0
    Company Name
    Enlitic, Inc.
    Labeler DUNS
    081152491
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-18
    Public Version
    4
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    6b6e1c7a-42db-4906-ada0-2abc9c733a12

    Device Description

    The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for integrations with other devices such as third-party PACs systems.

    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
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LMD System, Digital Image Communications, Radiological

    GMDN Terms

    Code Name
    57812 Radiology DICOM image processing application software

    Identifiers

    Type ID
    Primary 00860002304526