BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MP-2450

    DI: 04573596210277 · Model: MP-2450 · FUJIFILM HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MP-2450
    Primary DI
    04573596210277
    Version / Model
    MP-2450
    Company Name
    FUJIFILM HEALTHCARE CORPORATION
    Labeler DUNS
    680160734
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-13
    Public Version
    3
    Public Version Date
    2022-08-04
    Public Version Status
    Update
    Public Device Record Key
    2eb25df3-c69b-4277-87c3-8e445fa6821d

    Device Description

    Puncture Adapter

    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
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    OIJ Biopsy Needle Guide Kit

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Primary 04573596210277
    Previous 04562122951562

    Premarket Submissions

    Submission Number Supplement Number
    K140443 000
    K160559 000
    K162902 000
    K163505 000