{"publicDeviceRecordKey":"cf07aa73-9022-4e57-a68c-7623fe64ffea","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2026-04-08T00:00:00.000Z","devicePublishDate":"2015-09-10T00:00:00.000Z","deviceCommDistributionEndDate":"2024-05-26T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08809233103012","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Niti-S Esophageal Stent","versionModelNumber":"E1606","catalogNumber":"E1606","dunsNumber":"689484322","companyName":"TAEWOONGMEDICAL.CO.,LTD","deviceCount":1,"deviceDescription":"The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.  \nThe Niti-S Esophageal Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. \nThe stent is a flexible, expandable tubular device woven from one or two continuous pieces of Nitinol wire to avoid sharp edges.  At each end, the stent has a larger diameter resulting in a “dumbbell” shaped stent when viewed from an axial cross-section.  The Niti-S Esophageal Stent is provided in three configurations:  the Uncovered type, the Full Covered type and the Both Bare type.  The Uncovered-type stent is available in two diameters (6, 8mm), and five lengths (60, 80, 100, 120, and 150mm).  The Full Covered-type and the Both Bare-type stents are available in three diameters (6, 8, 10mm), and five lengths (60, 80, 100, 120, and 150mm).  It has 10 radiopaque markers.  \nThis device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.  The introducer system 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 usable lengths of the introducer is 70cm. \nOther information: \nThe shelf-life of Niti-S Esophageal Stent is 3 years.\nThe package is sterilized using Ethylene oxide. \nThe diameter of compatible guide wire is 0.038 inch (0.97mm). \nDo not use if package is damaged. \nDo not reuse or resterilize.\n","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"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"43573","gmdnPTName":"Bare-metal oesophageal stent","gmdnPTDefinition":"A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures (e.g., from intrinsic/extrinsic malignant tumours) or to reduce acute bleeding from oesophageal varices. It is typically a mesh structure made entirely of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted and expanded in situ with a balloon catheter, or inserted with a delivery device and self-expand upon release; disposable devices intended to assist implantation may be included with the stent.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ESW","productCodeName":"Prosthesis, Esophageal"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"16"},"sizeText":null,"sizeString":"Catheter Gauge: 16 French"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Catheter Usable Length: 70cm"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"6"},"sizeText":null,"sizeString":"Length: 6 Centimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"16"},"sizeText":null,"sizeString":"Outer Diameter: 16 Millimeter"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}