BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Radlink PH GPS Bracket

    DI: 00864908000131 · Model: PH BRACKET · RADLINK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Radlink PH GPS Bracket
    Primary DI
    00864908000131
    Version / Model
    PH BRACKET
    Company Name
    RADLINK, INC.
    Labeler DUNS
    069190036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-21
    Public Version
    1
    Public Version Date
    2019-07-01
    Public Version Status
    New
    Public Device Record Key
    4029e095-e07d-4ab3-bc61-e2461d63af38

    Device Description

    The PH GPS Bracket is comprised of Radlink proprietary software and hardware to duplicate Radlink user interface onto Philips reference monitor of the MVS utilizing a switch box that shifts the video signal between Philips and Radlink on the reference monitor. Not only does Radlink solution expand the field of view of Philips C-Arms utilizing Pano function, but it also facilitates intra-operative image analysis by assisting surgeons to evaluate acetabular cup position, limb length discrepancy, and femoral offset during Total Hip Arthroplasty. The PH GPS Bracket comes with software features such as image stitching and Surgeon’s Checklist™ software that provides surgeons with real-time feedback on orthopedic implant component positioning. Pre-operative images can be viewed on the device during surgery, which surgeons can use to reference against the intra-operative images captured during the procedure.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    17904 Computed radiography digital imaging scanner

    Identifiers

    Type ID
    Primary 00864908000131