BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-LINK R500 ROM Kit (Range of Motion)

    DI: 05060481690072 · Model: R500 · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-LINK R500 ROM Kit (Range of Motion)
    Primary DI
    05060481690072
    Version / Model
    R500
    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
    1
    Public Version Date
    2018-06-11
    Public Version Status
    New
    Public Device Record Key
    c806e7a7-4ebb-44f1-87b5-7e3d5abcfbc4

    Device Description

    Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. The Biometrics Range of Motion Kit (R500) provides precise electronic tools for: upper and lower extremity range of motion measurements

    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
    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
    ISD Exerciser, Measuring

    GMDN Terms

    Code Name
    33652 Electronic goniometer/kinesiology sensor

    Identifiers

    Type ID
    Primary 05060481690072