BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DenBite

    DI: 08717228440090 · Model: DBU2061 · DuPhaMed B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DenBite
    Primary DI
    08717228440090
    Version / Model
    DBU2061
    Company Name
    DuPhaMed B.V.
    Labeler DUNS
    413491023
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-24
    Public Version
    1
    Public Version Date
    2023-12-04
    Public Version Status
    New
    Public Device Record Key
    588c7e08-7d25-46fb-b51d-a78dcd79a268

    Device Description

    X-Ray sensor holder Introduction Pack Size 1, content: 1x bitewing - UDI 08717228441035 1x posterior Upper Left / Lower Right - UDI 08717228441554 1x posterior Upper Right / Lower Left - UDI 08717228441561 1x periapical Upper Left / Lower Right - UDI 08717228441233 1x periapical Upper Right / Lower Left - UDI 08717228441240 1x endo Upper Left / Lower Right - UDI 08717228441196 1x endo Upper Right / Lower Left - UDI 08717228441202 1x positioning ring - UDI 08717228441028

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EGZ Holder, Film, X-Ray

    GMDN Terms

    Code Name
    16205 Dental x-ray film holder, reusable

    Identifiers

    Type ID
    Primary 08717228440090