BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MDT NAVIGATED BIOPSY, COMPATIABLE 7D

    DI: 00815212026867 · Model: MB3000-7D-I · Izi Medical Products, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MDT NAVIGATED BIOPSY, COMPATIABLE 7D
    Primary DI
    00815212026867
    Version / Model
    MB3000-7D-I
    Company Name
    Izi Medical Products, LLC
    Labeler DUNS
    933506164
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-18
    Public Version
    1
    Public Version Date
    2024-03-26
    Public Version Status
    New
    Public Device Record Key
    665cd052-68c6-48d8-8fc0-05b1b0031a5c

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    38563 Brain biopsy procedure kit

    Identifiers

    Type ID
    Primary 00815212026867

    Premarket Submissions

    Submission Number Supplement Number
    K143241 000