BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CapSure Cloud

    DI: B377GMR1602008X0 · Model: 2.1.x · GLOBALMEDIA GROUP, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CapSure Cloud
    Primary DI
    B377GMR1602008X0
    Version / Model
    2.1.x
    Company Name
    GLOBALMEDIA GROUP, LLC
    Labeler DUNS
    103201849
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    6
    Public Version Date
    2023-12-11
    Public Version Status
    Update
    Public Device Record Key
    0142a98d-d670-4d03-9d16-98b62bec01a1
    Distribution End Date
    2023-12-08

    Device Description

    CapSure Cloud is a secure cloud-based web application for medical image archiving and management.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    60724 Multidisciplinary medical image management software

    Identifiers

    Type ID
    Primary B377GMR1602008X0

    Premarket Submissions

    Submission Number Supplement Number
    K130624 000