Esophageal TTS Stent EST2010F

GUDID 08809293832389

Fully Covered Esophageal Stent System

TAEWOONGMEDICAL.CO.,LTD

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08809293832389
• NIH Device Record Key: 1ab16e51-2db6-4e16-9ad1-366ee89c7186
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esophageal TTS Stent
• Version Model Number: EST2010F
• Catalog Number: EST2010F
• 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: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net
• Phone: +82319960641
• Email: sales@stent.net

Device Dimensions

• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 20 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809293832389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123205

FDA Product Code

• ESW: Prosthesis, Esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-26
• Device Publish Date: 2015-09-10

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