BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ViziLite®

    DI: D813PLS10080 · Model: PLS1008 · DEN-MAT HOLDINGS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ViziLite®
    Primary DI
    D813PLS10080
    Version / Model
    PLS1008
    Catalog Number
    PLS1008
    Company Name
    DEN-MAT HOLDINGS, LLC
    Labeler DUNS
    809857704
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-22
    Public Version
    1
    Public Version Date
    2022-09-30
    Public Version Status
    New
    Public Device Record Key
    98e28f5d-81b0-4bdc-95c3-5bb23aece2d8

    Device Description

    VIZILITE PRO PATIENT EYEWEAR

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NXV Diagnostic Light, Soft Tissue Detector

    GMDN Terms

    Code Name
    60827 Oral lesion examination light

    Identifiers

    Type ID
    Primary D813PLS10080

    Customer Contacts

    Phone
    18004336628
    Email
    [email protected]