BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Universal Adapter 10-15mm

    DI: 04589698450466 · Model: PS-BU-045 · MITAKA KOHKI CO., LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Universal Adapter 10-15mm
    Primary DI
    04589698450466
    Version / Model
    PS-BU-045
    Company Name
    MITAKA KOHKI CO., LTD.
    Labeler DUNS
    692666613
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-06
    Public Version
    2
    Public Version Date
    2019-03-13
    Public Version Status
    Update
    Public Device Record Key
    7d5a605d-ae1d-4d03-a019-9b88ccd26f46

    Device Description

    This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery
    GWG Endoscope, Neurological

    GMDN Terms

    Code Name
    62380 Surgical instrument assist arm system, power-adjusted

    Identifiers

    Type ID
    Primary 04589698450466