HANAROSTENT® Esophagus (NCN)

GUDID 08806367095893

Partially Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08806367095893
• NIH Device Record Key: fef5ccc4-d45b-4005-9ea8-855126a1190a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus (NCN)
• Version Model Number: EPB20090-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: +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: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 20 Millimeter
• Stent Length: 90 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	08806367095893 [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 (NCN)]

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• 08806367095930: Partially Covered metallic esophagus stent
• 08806367095923: Partially Covered metallic esophagus stent
• 08806367095916: Partially Covered metallic esophagus stent
• 08806367095909: Partially Covered metallic esophagus stent
• 08806367095893: Partially Covered metallic esophagus stent
• 08806367095886: Partially Covered metallic esophagus stent
• 08806367084224: Partially Covered metallic esophagus stent
• 08806367073860: Partially Covered metallic esophagus stent
• 08806367069177: Partially Covered metallic esophagus stent
• 08806367040688: Partially Covered metallic esophagus stent
• 08806367039781: Partially Covered metallic esophagus stent
• 08806367039767: Partially Covered metallic esophagus stent
• 08806367039750: Partially Covered metallic esophagus stent
• 08806367039743: Partially Covered metallic esophagus stent
• 08806367039736: Partially Covered metallic esophagus stent
• 08806367039583: Partially Covered metallic esophagus stent
• 08806367039576: Partially Covered metallic esophagus stent
• 08806367039552: Partially Covered metallic esophagus stent
• 08806367039545: Partially Covered metallic esophagus stent
• 08806367039507: Partially Covered metallic esophagus stent
• 08806367039491: Partially Covered metallic esophagus stent
• 08806367039484: Partially Covered metallic esophagus stent