BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    iGUIDE

    DI: 04056719001704 · Model: P10603-109 · 3C-Medical Intelligence GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iGUIDE
    Primary DI
    04056719001704
    Version / Model
    P10603-109
    Catalog Number
    P10603-109
    Company Name
    3C-Medical Intelligence GmbH
    Labeler DUNS
    314546664
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-23
    Public Version
    5
    Public Version Date
    2023-12-15
    Public Version Status
    Update
    Public Device Record Key
    2afc8cff-aad4-4471-a6a0-b8007cb9c0e1
    Distribution End Date
    2021-10-12

    Device Description

    iGUIDE® Software 2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module

    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYE Accelerator, Linear, Medical

    GMDN Terms

    Code Name
    40687 Accelerator system table, powered

    Identifiers

    Type ID
    Primary 04056719001704

    Premarket Submissions

    Submission Number Supplement Number
    K143485 000