{"publicDeviceRecordKey":"ee721076-12fb-4920-b7fe-29183fef1972","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-04-07T00:00:00.000Z","devicePublishDate":"2015-09-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08809233100486","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Niti-S Biliary Stent","versionModelNumber":"TD0810","catalogNumber":"TD0810","dunsNumber":"689484322","companyName":"TAEWOONGMEDICAL.CO.,LTD","deviceCount":1,"deviceDescription":"The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.\nThe 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.  \nThe 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.\nThere 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. \nOther information: \nThe package is sterilized using Ethylene oxide. \nThe diameter of compatible guide wire is 0.035 inch (0.89mm). \nDo not use if package is damaged. \nDo not reuse or resterilize. ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"323-692-0028","phoneExtension":null,"email":"minsoo@taewoongusa.com"},{"phone":"+82319960641","phoneExtension":null,"email":"contact@stent.net"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K073667","supplementNumber":"000"},{"submissionNumber":"K251123","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"43691","gmdnPTName":"Bare-metal biliary stent","gmdnPTDefinition":"A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FGE","productCodeName":"Catheter, Biliary, Diagnostic"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"100"},"sizeText":null,"sizeString":"Length: 100 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"8"},"sizeText":null,"sizeString":"Outer Diameter: 8 Millimeter"},{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"8"},"sizeText":null,"sizeString":"Catheter Gauge: 8 French"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Catheter Usable Length: 50cm"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}