HANAROSTENT® Esophagus TTS(CCC)

GUDID 08806367088413

Full Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08806367088413
• NIH Device Record Key: a4687e50-f4e6-40ad-8250-fe982ee9390f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus TTS(CCC)
• Version Model Number: ECBA-20-060-230
• 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: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr
• Phone: +827043047405
• Email: andrew@mitech.co.kr

Device Dimensions

• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0

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
• 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
• 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	08806367088413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200860

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: 2020-06-08
• Device Publish Date: 2020-05-29

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

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• 08806367088512: Full Covered metallic esophagus stent
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• 08806367088482: Full Covered metallic esophagus stent
• 08806367088475: Full Covered metallic esophagus stent
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• 08806367088451: Full Covered metallic esophagus stent
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• 08806367088369: Full Covered metallic esophagus stent
• 08806367088352: Full Covered metallic esophagus stent
• 08806367088345: Full Covered metallic esophagus stent
• 08806367088338: Full Covered metallic esophagus stent
• 08806367088321: Full Covered metallic esophagus stent
• 08806367088314: Full Covered metallic esophagus stent
• 08806367088307: Full Covered metallic esophagus stent
• 08806367088291: Full Covered metallic esophagus stent
• 08806367088284: Full Covered metallic esophagus stent
• 08806367088277: Full Covered metallic esophagus stent
• 08806367088260: Full Covered metallic esophagus stent
• 08806367088253: Full Covered metallic esophagus stent
• 08806367088246: Full Covered metallic esophagus stent
• 08806367088239: Full Covered metallic esophagus stent
• 08806367088222: Full Covered metallic esophagus stent
• 08806367088215: Full Covered metallic esophagus stent
• 08806367088208: Full Covered metallic esophagus stent