BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visionary by 3D Dental

    DI: 00817169025191 · Model: XBA2 · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Visionary by 3D Dental
    Primary DI
    00817169025191
    Version / Model
    XBA2
    Catalog Number
    XBA2
    Company Name
    3D DENTAL DESIGNS AND DEVELOPMENT, LLC
    Labeler DUNS
    080194935
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-10
    Public Version
    1
    Public Version Date
    2023-01-18
    Public Version Status
    New
    Public Device Record Key
    d89b8b57-6e0a-4ade-be5e-ba404313f2ca

    Device Description

    VISIONARY BARRIER ENVELOPE #2 100/BX

    Device Characteristics

    Single Use
    Yes
    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
    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
    EGZ Holder, Film, X-Ray

    GMDN Terms

    Code Name
    45256 Digital imaging cassette/storage phosphor screen, dental

    Identifiers

    Type ID
    Primary 00817169025191