BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Niti-S Biliary Stent

    DI: 08809233100479 · Model: TD0809 · TAEWOONGMEDICAL.CO.,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Niti-S Biliary Stent
    Primary DI
    08809233100479
    Version / Model
    TD0809
    Catalog Number
    TD0809
    Company Name
    TAEWOONGMEDICAL.CO.,LTD
    Labeler DUNS
    689484322
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-10
    Public Version
    4
    Public Version Date
    2022-04-08
    Public Version Status
    Update
    Public Device Record Key
    ca825bd4-f0c6-458e-849b-f261a6334b06

    Device Description

    The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FGE Catheter, Biliary, Diagnostic

    GMDN Terms

    Code Name
    43691 Bare-metal biliary stent

    Identifiers

    Type ID
    Primary 08809233100479

    Customer Contacts

    Phone
    +82319960641
    Email
    [email protected]
    Phone
    323-692-0028
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K073667 000

    Device Sizes

    Type Value Unit Text
    Length 90 Millimeter
    Outer Diameter 8 Millimeter
    Catheter Gauge 8 French
    Device Size Text, specify Catheter Usable Length: 50cm

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius