HANAROSTENT® Esophagus Asymmetric (CCC)

GUDID 08806367095978

Full Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08806367095978
• NIH Device Record Key: 2c7a61f1-d52d-4f86-9300-48a46ed785c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Esophagus Asymmetric (CCC)
• Version Model Number: ECN22090-Z070
• 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: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 Millimeter
• Stent Length: 90 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 22 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	08806367095978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213251

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 Asymmetric (CCC)]

• 08806367096029: Full Covered metallic esophagus stent
• 08806367096012: Full Covered metallic esophagus stent
• 08806367096005: Full Covered metallic esophagus stent
• 08806367095992: Full Covered metallic esophagus stent
• 08806367095985: Full Covered metallic esophagus stent
• 08806367095978: Full Covered metallic esophagus stent
• 08806367095961: Full Covered metallic esophagus stent
• 08806367044778: Full Covered metallic esophagus stent
• 08806367044761: Full Covered metallic esophagus stent
• 08806367044754: Full Covered metallic esophagus stent
• 08806367044747: Full Covered metallic esophagus stent
• 08806367044730: Full Covered metallic esophagus stent
• 08806367044723: Full Covered metallic esophagus stent
• 08806367044716: Full Covered metallic esophagus stent
• 08806367044709: Full Covered metallic esophagus stent
• 08806367044563: Full Covered metallic esophagus stent
• 08806367044556: Full Covered metallic esophagus stent
• 08806367044549: Full Covered metallic esophagus stent
• 08806367044532: Full Covered metallic esophagus stent
• 08806367044525: Full Covered metallic esophagus stent
• 08806367044518: Full Covered metallic esophagus stent
• 08806367044501: Full Covered metallic esophagus stent
• 08806367044495: Full Covered metallic esophagus stent
• 08806367044440: Full Covered metallic esophagus stent
• 08806367044433: Full Covered metallic esophagus stent
• 08806367044426: Full Covered metallic esophagus stent
• 08806367044419: Full Covered metallic esophagus stent
• 08806367044402: Full Covered metallic esophagus stent
• 08806367043351: Full Covered metallic esophagus stent
• 08806367020376: Full Covered metallic esophagus stent
• 08806367020369: Full Covered metallic esophagus stent
• 08806367020352: Full Covered metallic esophagus stent