BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AVALON BIOMED

    DI: 06942512501184 · Model: BlueShaper PRO sterile files 21mm Z6 (6 units) · Shenzhen Denco Medical Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    AVALON BIOMED
    Primary DI
    06942512501184
    Version / Model
    BlueShaper PRO sterile files 21mm Z6 (6 units)
    Company Name
    Shenzhen Denco Medical Co., Ltd
    Labeler DUNS
    543035008
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-21
    Public Version
    1
    Public Version Date
    2025-07-29
    Public Version Status
    New
    Public Device Record Key
    02766a71-667e-4c1a-80d5-ae47e7f8af27
    Distribution End Date
    2030-07-21

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKS File, Pulp Canal, Endodontic

    GMDN Terms

    Code Name
    63720 Manual endodontic file/rasp, single-use

    Identifiers

    Type ID
    Primary 06942512501184