BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Patient tracker EM-D mini

    DI: B057U1031300 · Model: 1.0 · Scopis GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Patient tracker EM-D mini
    Primary DI
    B057U1031300
    Version / Model
    1.0
    Catalog Number
    U1 031 30
    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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    ead8de24-9fc2-463e-88bc-09e8aa198b43

    Device Description

    The Patient Tracker EM-D mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable. The Patient Tracker EM-D mini is provided non-sterile and is intended for high-level disinfection only. The Patient Tracker EM-D mini is reusable.

    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
    43267 Patient positioning sensor

    Identifiers

    Type ID
    Primary B057U1031300