BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OrthoNext™ Platform System Software

    DI: 18059015375848 · Model: 1.1 · ORTHOFIX SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OrthoNext™ Platform System Software
    Primary DI
    18059015375848
    Version / Model
    1.1
    Catalog Number
    TLHEXMODULESW1.1
    Company Name
    ORTHOFIX SRL
    Labeler DUNS
    438793622
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-31
    Public Version
    3
    Public Version Date
    2025-10-24
    Public Version Status
    Update
    Public Device Record Key
    f3f7e882-d8f6-40b5-b856-a69fa198b15e

    Device Description

    POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE

    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
    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
    QIH Automated Radiological Image Processing Software

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 18059015375848

    Customer Contacts

    Phone
    +0390456719000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K242270 000