BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Flow Dental

    DI: 08717228442537 · Model: Earflow34 · DuPhaMed B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    150

    Basic Information

    Brand Name
    Flow Dental
    Primary DI
    08717228442537
    Version / Model
    Earflow34
    Catalog Number
    81500
    Company Name
    DuPhaMed B.V.
    Labeler DUNS
    413491023
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    150
    Record Status
    Published
    Publish Date
    2023-11-23
    Public Version
    1
    Public Version Date
    2023-12-01
    Public Version Status
    New
    Public Device Record Key
    6ca0df73-bdc8-4017-8a5b-2b0c0d656cd9

    Device Description

    Confee Ears Disposable ear sleeves for CBCT exams

    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
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Unit of Use 08717228441011
    Primary 08717228442537