HANAROSTENT® Esophagus (CCC)

GUDID 08806367095800

Full Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08806367095800
• NIH Device Record Key: 8d082d38-2719-4409-9141-9b3a4d082c2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus (CCC)
• Version Model Number: HES-A-22-080-070
• 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: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr
• Phone: +827043047414
• Email: paul@mitech.co.kr

Device Dimensions

• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 80 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806367095800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201160

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: 2022-01-10
• Device Publish Date: 2021-12-31

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

• 08806367095879: Full Covered metallic esophagus stent
• 08806367095862: Full Covered metallic esophagus stent
• 08806367095855: Full Covered metallic esophagus stent
• 08806367095848: Full Covered metallic esophagus stent
• 08806367095831: Full Covered metallic esophagus stent
• 08806367095824: Full Covered metallic esophagus stent
• 08806367095817: Full Covered metallic esophagus stent
• 08806367095800: Full Covered metallic esophagus stent
• 08806367095794: Full Covered metallic esophagus stent
• 08806367095787: Full Covered metallic esophagus stent
• 08806367095770: Full Covered metallic esophagus stent
• 08806367095763: Full Covered metallic esophagus stent
• 08806367095756: Full Covered metallic esophagus stent
• 08806367095749: Full Covered metallic esophagus stent
• 08806367095732: Full Covered metallic esophagus stent
• 08806367095725: Full Covered metallic esophagus stent
• 08806367095718: Full Covered metallic esophagus stent
• 08806367095701: Full Covered metallic esophagus stent
• 08806367095695: Full Covered metallic esophagus stent
• 08806367095688: Full Covered metallic esophagus stent
• 08806367095671: Full Covered metallic esophagus stent
• 08806367095657: Full Covered metallic esophagus stent
• 08806367095640: Full Covered metallic esophagus stent
• 08806367095633: Full Covered metallic esophagus stent
• 08806367058249: Full Covered metallic esophagus stent
• 08806367046796: Full Covered metallic esophagus stent
• 08806367040350: Full Covered metallic esophagus stent
• 08806367024961: Full Covered metallic esophagus stent
• 08806367024824: Full Covered metallic esophagus stent
• 08806367024817: Full Covered metallic esophagus stent
• 08806367024800: Full Covered metallic esophagus stent
• 08806367024794: Full Covered metallic esophagus stent
• 08806367021830: Full Covered metallic esophagus stent
• 08806367021823: Full Covered metallic esophagus stent
• 08806367021816: Full Covered metallic esophagus stent
• 08806367004222: Full Covered metallic esophagus stent
• 08806367004215: Full Covered metallic esophagus stent
• 08806367004208: Full Covered metallic esophagus stent
• 08806367004192: Full Covered metallic esophagus stent
• 08806367004185: Full Covered metallic esophagus stent
• 08806367004178: Full Covered metallic esophagus stent
• 08806367004161: Full Covered metallic esophagus stent
• 08806367004147: Full Covered metallic esophagus stent
• 08806367004130: HES-18-080-070