BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cortical Drill

    DI: 08800011262976 · Model: OTCD5500 · POINTIMPLANT Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cortical Drill
    Primary DI
    08800011262976
    Version / Model
    OTCD5500
    Company Name
    POINTIMPLANT Co., Ltd.
    Labeler DUNS
    695333960
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-21
    Public Version
    2
    Public Version Date
    2023-11-16
    Public Version Status
    Update
    Public Device Record Key
    9a168517-b875-4bc6-a352-2026d67004f9

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    DZA Drill, Dental, Intraoral

    GMDN Terms

    Code Name
    45714 Fixture/appliance dental drill bit, reusable

    Identifiers

    Type ID
    Primary 08800011262976