BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-LINK N400 Large Goniometer

    DI: 05060481690065 · Model: N400 · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-LINK N400 Large Goniometer
    Primary DI
    05060481690065
    Version / Model
    N400
    Company Name
    BIOMETRICS LIMITED
    Labeler DUNS
    519969810
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-10
    Public Version
    2
    Public Version Date
    2018-08-10
    Public Version Status
    Update
    Public Device Record Key
    55bc5efe-9c76-42a7-819d-dac62432655e

    Device Description

    Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting: Wrist, Forearm, Elbow, Shoulder, Hip, Knee, Ankle, Documentation of amputation, ankylosis, and arthrodesis for the above joints This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

    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
    Yes
    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
    ISD Exerciser, Measuring
    KQX Goniometer, Ac-Powered

    GMDN Terms

    Code Name
    33652 Electronic goniometer/kinesiology sensor

    Identifiers

    Type ID
    Primary 05060481690065