BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NGB-019 Needle-guided Bracket

    DI: 06944904049892 · Model: 120-001738-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NGB-019 Needle-guided Bracket
    Primary DI
    06944904049892
    Version / Model
    120-001738-00
    Company Name
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    Labeler DUNS
    654671304
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    9
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    01a851a5-6364-4846-ad0c-28a8e3663808

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    OIJ Biopsy Needle Guide Kit

    GMDN Terms

    Code Name
    58248 Ultrasound imaging system tracking positioner, reusable

    Identifiers

    Type ID
    Primary 06944904049892

    Customer Contacts

    Phone
    +8675581888998
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K150204 000
    K181637 000