HANAROSTENT® Esophagus (CCC)

GUDID 08806367046796

Full Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent

• Primary Device ID: 08806367046796
• NIH Device Record Key: df732fed-d431-4354-8764-937f422c905d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus (CCC)
• Version Model Number: HES-22-150-070
• 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: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr
• Phone: +827043047450
• Email: inae116@mitech.co.kr

Device Dimensions

• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Lumen/Inner Diameter: 22 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
• 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	08806367046796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093537

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: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2017-07-03

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

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• 08806367095800: Full Covered metallic esophagus stent
• 08806367095794: Full Covered metallic esophagus stent
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• 08806367024961: Full Covered metallic esophagus stent
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• 08806367004130: HES-18-080-070