BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OSUNG MND

    DI: 08800075626158 · Model: 2MHC2 · OSUNG MND Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OSUNG MND
    Primary DI
    08800075626158
    Version / Model
    2MHC2
    Company Name
    OSUNG MND Co., Ltd.
    Labeler DUNS
    688207479
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-23
    Public Version
    2
    Public Version Date
    2025-11-03
    Public Version Status
    Update
    Public Device Record Key
    57001528-af38-49d1-8379-24e1b42a14d4
    Distribution End Date
    2025-10-31

    Device Description

    A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    EJB Handle, Instrument, Dental

    GMDN Terms

    Code Name
    64304 Manual non-rotary dental instrument handle

    Identifiers

    Type ID
    Primary 08800075626158