BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OSUNG MND

    DI: 08800075621269 · Model: MICSA10 · 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
    08800075621269
    Version / Model
    MICSA10
    Company Name
    OSUNG MND Co., Ltd.
    Labeler DUNS
    688207479
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-21
    Public Version
    1
    Public Version Date
    2024-02-29
    Public Version Status
    New
    Public Device Record Key
    2f02a18e-68cb-438e-b34c-343a7edc3c0a

    Device Description

    A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. 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
    GFA Blade, Saw, General & Plastic Surgery, Surgical

    GMDN Terms

    Code Name
    44984 Surgical saw blade, oscillating, reusable

    Identifiers

    Type ID
    Primary 08800075621269