HANAROSTENT® Esophagus TTS(NCN)

GUDID 08806367088710

Partially Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08806367088710
• NIH Device Record Key: ae160457-278c-4974-9176-74a3a90691c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus TTS(NCN)
• Version Model Number: EPBA-18-110-230
• 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: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 18 Millimeter
• Stent Length: 110 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	08806367088710 [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(NCN)]

• 08806367088994: Partially Covered metallic esophagus stent
• 08806367088987: Partially Covered metallic esophagus stent
• 08806367088970: Partially Covered metallic esophagus stent
• 08806367088963: Partially Covered metallic esophagus stent
• 08806367088956: Partially Covered metallic esophagus stent
• 08806367088949: Partially Covered metallic esophagus stent
• 08806367088932: Partially Covered metallic esophagus stent
• 08806367088925: Partially Covered metallic esophagus stent
• 08806367088918: Partially Covered metallic esophagus stent
• 08806367088901: Partially Covered metallic esophagus stent
• 08806367088895: Partially Covered metallic esophagus stent
• 08806367088888: Partially Covered metallic esophagus stent
• 08806367088871: Partially Covered metallic esophagus stent
• 08806367088864: Partially Covered metallic esophagus stent
• 08806367088857: Partially Covered metallic esophagus stent
• 08806367088840: Partially Covered metallic esophagus stent
• 08806367088833: Partially Covered metallic esophagus stent
• 08806367088826: Partially Covered metallic esophagus stent
• 08806367088819: Partially Covered metallic esophagus stent
• 08806367088802: Partially Covered metallic esophagus stent
• 08806367088796: Partially Covered metallic esophagus stent
• 08806367088789: Partially Covered metallic esophagus stent
• 08806367088772: Partially Covered metallic esophagus stent
• 08806367088765: Partially Covered metallic esophagus stent
• 08806367088758: Partially Covered metallic esophagus stent
• 08806367088741: Partially Covered metallic esophagus stent
• 08806367088734: Partially Covered metallic esophagus stent
• 08806367088727: Partially Covered metallic esophagus stent
• 08806367088710: Partially Covered metallic esophagus stent
• 08806367088703: Partially Covered metallic esophagus stent
• 08806367088697: Partially Covered metallic esophagus stent
• 08806367088680: Partially Covered metallic esophagus stent
• 08806367088673: Partially Covered metallic esophagus stent
• 08806367088666: Partially Covered metallic esophagus stent
• 08806367088659: Partially Covered metallic esophagus stent
• 08806367088642: Partially Covered metallic esophagus stent
• 08806367088635: Partially Covered metallic esophagus stent
• 08806367088628: Partially Covered metallic esophagus stent
• 08806367088611: Partially Covered metallic esophagus stent
• 08806367088604: Partially Covered metallic esophagus stent