HANAROSTENT® Esophagus Upper (CCC)

GUDID 08809867585185

Full Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent

• Primary Device ID: 08809867585185
• NIH Device Record Key: 8468eb22-f5cf-4f57-9a93-19409aaa5f1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus Upper (CCC)
• Version Model Number: ECP20110-X070
• Company DUNS: 688454359
• Company Name: M.I.Tech 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +821042945040
• Email: skim@mitechglobal.com
• Phone: +821042945040
• Email: skim@mitechglobal.com
• Phone: +821042945040
• Email: skim@mitechglobal.com
• Phone: +821042945040
• Email: skim@mitechglobal.com
• Phone: +821042945040
• Email: skim@mitechglobal.com
• Phone: +821042945040
• Email: skim@mitechglobal.com
• Phone: +821042945040
• Email: skim@mitechglobal.com

Device Dimensions

• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 110 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809867585185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253327

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: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [HANAROSTENT® Esophagus Upper (CCC)]

• 08809867585222: Full Covered metallic esophagus stent
• 08809867585215: Full Covered metallic esophagus stent
• 08809867585208: Full Covered metallic esophagus stent
• 08809867585192: Full Covered metallic esophagus stent
• 08809867585185: Full Covered metallic esophagus stent
• 08809867585178: Full Covered metallic esophagus stent
• 08809867585161: Full Covered metallic esophagus stent
• 08809867585154: Full Covered metallic esophagus stent
• 08809867585147: Full Covered metallic esophagus stent
• 08809867585130: Full Covered metallic esophagus stent
• 08809867585123: Full Covered metallic esophagus stent
• 08809867585116: Full Covered metallic esophagus stent
• 08809867585109: Full Covered metallic esophagus stent
• 08809867585093: Full Covered metallic esophagus stent
• 08809867585086: Full Covered metallic esophagus stent
• 08809867585079: Full Covered metallic esophagus stent