BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VERA

    DI: 00860001498400 · Model: 3.3.2-2.13.0 · REFLEXION HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VERA
    Primary DI
    00860001498400
    Version / Model
    3.3.2-2.13.0
    Company Name
    REFLEXION HEALTH, INC.
    Labeler DUNS
    078764018
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-30
    Public Version
    2
    Public Version Date
    2021-06-08
    Public Version Status
    Update
    Public Device Record Key
    98b18c79-9809-4cc6-982e-6ba7ea47ba5e

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    LXJ System, Optical Position/Movement Recording

    GMDN Terms

    Code Name
    60925 Virtual-display rehabilitation system, non-supportive, clinical

    Identifiers

    Type ID
    Primary 00860001498400

    Premarket Submissions

    Submission Number Supplement Number
    K150462 000