Niti-S Esophageal Stent ES1806B

GUDID 08809233103371

The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The Niti-S Esophageal Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The 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. This 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. Other information: The shelf-life of Niti-S Esophageal Stent is 3 years. The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.038 inch (0.97mm). Do not use if package is damaged. Do not reuse or resterilize.

TAEWOONGMEDICAL.CO.,LTD

Polymer-metal oesophageal stent
Primary Device ID08809233103371
NIH Device Record Key420f3d80-de1a-4a16-8094-52a5b4b5785f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNiti-S Esophageal Stent
Version Model NumberES1806B
Catalog NumberES1806B
Company DUNS689484322
Company NameTAEWOONGMEDICAL.CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net
Phone323-692-0028
Emaildanny@stent.net

Device Dimensions

Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter
Device Size Text, specify0
Catheter Gauge16 French
Device Size Text, specify0
Length6 Centimeter
Outer Diameter18 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809233103371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ESWProsthesis, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-11-28
Device Publish Date2015-09-10

On-Brand Devices [Niti-S Esophageal Stent]

08809233103470The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103463The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103456The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103449The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103432The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103418The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103401The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103395The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103388The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103371The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103357The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103340The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103333The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103326The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103319The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103296The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103289The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103272The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103265The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103258The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103234The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103227The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103210The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103203The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103197The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103173The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103166The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103159The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103142The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
08809233103135The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or
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