BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIA-PEN

    DI: 08806383538947 · Model: DIA-PEN,REGULAR KIT · DiaDent Group International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIA-PEN
    Primary DI
    08806383538947
    Version / Model
    DIA-PEN,REGULAR KIT
    Catalog Number
    4002-1001
    Company Name
    DiaDent Group International
    Labeler DUNS
    687789453
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-26
    Public Version
    1
    Public Version Date
    2020-06-03
    Public Version Status
    New
    Public Device Record Key
    d02f9a7f-9777-4083-9936-6ca402d7dfb6

    Device Description

    Dia-Pen supports warm vertical compaction and has proven to be effectice as an integral part of downpack obturator system.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKR Plugger, Root Canal, Endodontic

    GMDN Terms

    Code Name
    45247 Endodontic obturation system

    Identifiers

    Type ID
    Primary 08806383538947

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 40 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    30 – 85 Percent (%) Relative Humidity