BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hybrid Navigation Unit EM

    DI: B057U2040040 · Model: 2.2 · Scopis GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hybrid Navigation Unit EM
    Primary DI
    B057U2040040
    Version / Model
    2.2
    Catalog Number
    U2 040 04
    Company Name
    Scopis GmbH
    Labeler DUNS
    341702266
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-04
    Public Version
    3
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    f701445a-ae24-43e9-a8f0-13c3bf37fa3a

    Device Description

    The Hybrid Navigation Unit EM is a high performance computer workstation with built-in electromagnetic Localization System. The workstation runs the navigation software NOVA which imports radiologic image via DICOM.

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PGW Ear, Nose, And Throat Stereotaxic Instrument

    GMDN Terms

    Code Name
    62783 Electromagnetic/optical surgical navigation device tracking system

    Identifiers

    Type ID
    Primary B057U2040040