BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Codonics Horizon® Operating Software

    DI: 00814905020045 · Model: 2.1.3 · CODONICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Codonics Horizon® Operating Software
    Primary DI
    00814905020045
    Version / Model
    2.1.3
    Company Name
    CODONICS INC.
    Labeler DUNS
    101533727
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-23
    Public Version
    4
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    5317e892-3c22-4633-82a3-a2cce6d7e01e

    Device Description

    V2.1.3 Operating Software for Codonics Horizon® Imagers serial number prefix 50C, 51C, and 52C

    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
    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
    LMC Camera, Multi Format, Radiological

    GMDN Terms

    Code Name
    35580 Diagnostic-imaging multiformat camera

    Identifiers

    Type ID
    Primary 00814905020045

    Customer Contacts

    Phone
    4402431334
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K060440 000