Esophageal TTS Stent EST1815F

GUDID 08809744975535

Fully Covered Esophageal Stent System

TAEWOONGMEDICAL.CO.,LTD

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08809744975535
• NIH Device Record Key: df5f133d-8cbc-4666-8a96-80b421fb6703
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esophageal TTS Stent
• Version Model Number: EST1815F
• Catalog Number: EST1815F
• Company DUNS: 689484322
• Company Name: TAEWOONGMEDICAL.CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com

Device Dimensions

• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 15 Centimeter
• Outer Diameter: 18 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809744975535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221482

FDA Product Code

• ESW: Prosthesis, Esophageal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-07
• Device Publish Date: 2022-06-29

On-Brand Devices [Esophageal TTS Stent]

• 08809744973500: Partially Covered Esophageal Stent System
• 08809744973494: Partially Covered Esophageal Stent System
• 08809744973487: Partially Covered Esophageal Stent System
• 08809744973470: Partially Covered Esophageal Stent System
• 08809744973463: Partially Covered Esophageal Stent System
• 08809744973456: Partially Covered Esophageal Stent System
• 08809744973449: Partially Covered Esophageal Stent System
• 08809744973432: Partially Covered Esophageal Stent System
• 08809744973425: Partially Covered Esophageal Stent System
• 08809744973418: Partially Covered Esophageal Stent System
• 08809744973401: Partially Covered Esophageal Stent System
• 08809744973395: Partially Covered Esophageal Stent System
• 08809744973388: Partially Covered Esophageal Stent System
• 08809744973371: Partially Covered Esophageal Stent System
• 08809744973364: Partially Covered Esophageal Stent System
• 08809744973357: Partially Covered Esophageal Stent System
• 08809744973340: Partially Covered Esophageal Stent System
• 08809744973333: Partially Covered Esophageal Stent System
• 08809744973326: Fully Covered Esophageal Stent System
• 08809744973319: Fully Covered Esophageal Stent System
• 08809744973302: Fully Covered Esophageal Stent System
• 08809744973296: Fully Covered Esophageal Stent System
• 08809744973289: Fully Covered Esophageal Stent System
• 08809744973272: Fully Covered Esophageal Stent System
• 08809744973265: Fully Covered Esophageal Stent System
• 08809744973258: Fully Covered Esophageal Stent System
• 08809744973241: Fully Covered Esophageal Stent System
• 08809744973234: Fully Covered Esophageal Stent System
• 08809744973227: Fully Covered Esophageal Stent System
• 08809744973210: Fully Covered Esophageal Stent System
• 08809744973203: Fully Covered Esophageal Stent System
• 08809744973197: Fully Covered Esophageal Stent System
• 08809744973180: Fully Covered Esophageal Stent System
• 08809744973173: Fully Covered Esophageal Stent System
• 08809744973166: Fully Covered Esophageal Stent System
• 08809744973142: Partially Covered Esophageal Stent System
• 08809744973135: Partially Covered Esophageal Stent System
• 08809744973128: Partially Covered Esophageal Stent System
• 08809744973111: Partially Covered Esophageal Stent System
• 08809744973104: Partially Covered Esophageal Stent System
• 08809744973098: Partially Covered Esophageal Stent System
• 08809744972961: Fully Covered Esophageal Stent System
• 08809744972954: Fully Covered Esophageal Stent System
• 08809744972947: Fully Covered Esophageal Stent System
• 08809744972930: Fully Covered Esophageal Stent System
• 08809744972923: Fully Covered Esophageal Stent System
• 08809744972916: Fully Covered Esophageal Stent System
• 08809744972763: Fully Covered Esophageal Stent System
• 08809293833171: Partially Covered Esophageal Stent System
• 08809293833164: Partially Covered Esophageal Stent System