BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Clear-Jet Injection Catheter

    DI: 08809327352401 · Model: FM-EI0002(1800)(0.05T) · FINEMEDIX CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Clear-Jet Injection Catheter
    Primary DI
    08809327352401
    Version / Model
    FM-EI0002(1800)(0.05T)
    Company Name
    FINEMEDIX CO.,LTD.
    Labeler DUNS
    688256864
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-12
    Public Version
    1
    Public Version Date
    2019-04-22
    Public Version Status
    New
    Public Device Record Key
    b2486671-7f74-4ef0-9f1c-227c6e1b769c

    Device Description

    23G-4mm/ 0.05T/ 1,800mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

    GMDN Terms

    Code Name
    38825 General-purpose endoscopic needle, single-use

    Identifiers

    Type ID
    Package 18809327352408
    Primary 08809327352401

    Customer Contacts

    Phone
    +82537418388
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181690 000