BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Radlink Sensor

    DI: 00866389000174 · Model: SENSOR · RADLINK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Radlink Sensor
    Primary DI
    00866389000174
    Version / Model
    SENSOR
    Company Name
    RADLINK, INC.
    Labeler DUNS
    069190036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    6bb72b61-becb-428a-95bf-01880e32e003

    Device Description

    The Radink Sensor uses a combination of a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer to locate a patient's body in 3D space. It is calibrated to the patient's original position immediately prior to the surgery so any movement is tracked and the patient can be returned to the original position at any time during or after the surgery.

    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
    KQX Goniometer, Ac-Powered

    GMDN Terms

    Code Name
    33652 Electronic goniometer/kinesiology sensor

    Identifiers

    Type ID
    Primary 00866389000174