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    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-LINK N200 Large Goniometer

    DI: 05060481692434 · Model: N200 · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-LINK N200 Large Goniometer
    Primary DI
    05060481692434
    Version / Model
    N200
    Company Name
    BIOMETRICS LIMITED
    Labeler DUNS
    519969810
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-09
    Public Version
    1
    Public Version Date
    2018-09-10
    Public Version Status
    New
    Public Device Record Key
    7d315c0a-e8fe-4662-8823-10082490be15

    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 EN 60601-1:1990 including Amendments A1, A2 and A13

    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
    KQX Goniometer, Ac-Powered
    ISD Exerciser, Measuring

    GMDN Terms

    Code Name
    33652 Electronic goniometer/kinesiology sensor

    Identifiers

    Type ID
    Primary 05060481692434