BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FONA ELITE

    DI: D764B12110451 · Model: B1211045 · SIRONA DENTAL, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FONA ELITE
    Primary DI
    D764B12110451
    Version / Model
    B1211045
    Company Name
    SIRONA DENTAL, INC.
    Labeler DUNS
    078613913
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    5
    Public Version Date
    2022-12-09
    Public Version Status
    Update
    Public Device Record Key
    005ea307-780e-4c75-9a03-0dcee142705d

    Device Description

    FONA ELITE SENSOR SIZE 2 KIT

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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
    MUH System,X-Ray,Extraoral Source,Digital
    EHD Unit, X-Ray, Extraoral With Timer
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    44905 Dental digital imaging sensor, intraoral

    Identifiers

    Type ID
    Primary D764B12110451

    Customer Contacts

    Phone
    (877) 724-4254
    Email
    [email protected]