BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EZU-PA3U

    DI: 04573596210796 · Model: EZU-PA3U · FUJIFILM HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EZU-PA3U
    Primary DI
    04573596210796
    Version / Model
    EZU-PA3U
    Company Name
    FUJIFILM HEALTHCARE CORPORATION
    Labeler DUNS
    680160734
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-18
    Public Version
    3
    Public Version Date
    2022-08-04
    Public Version Status
    Update
    Public Device Record Key
    0c8148fe-8996-4774-a2a7-d19bb63c24f5

    Device Description

    Puncture Guide Fixture

    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 04573596210796
    Previous 04580292773982