BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Denco

    DI: 06970514912684 · Model: 21mm Barbed broaches #1 · SHENZHEN DENCO MEDICAL CO., LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Denco
    Primary DI
    06970514912684
    Version / Model
    21mm Barbed broaches #1
    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
    2023-04-19
    Public Version
    1
    Public Version Date
    2023-04-27
    Public Version Status
    New
    Public Device Record Key
    b9ce0da7-946a-49b6-91f5-494156077ace

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKS File, Pulp Canal, Endodontic

    GMDN Terms

    Code Name
    63694 Sonic endodontic broach

    Identifiers

    Type ID
    Primary 06970514912684