Esophageal TTS Stent EST2012B

GUDID 08809293833157

Partially Covered Esophageal Stent System

TAEWOONGMEDICAL.CO.,LTD

Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent

• Primary Device ID: 08809293833157
• NIH Device Record Key: 42bef218-6e83-436d-8f94-ee5e86a0e6b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esophageal TTS Stent
• Version Model Number: EST2012B
• Catalog Number: EST2012B
• 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: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net
• Phone: 323-692-0028
• Email: danny@stent.net

Device Dimensions

• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 10.5 French
• Device Size Text, specify: 0

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	08809293833157 [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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