HANAROSTENT® Trachea/Bronchium(CCC)

GUDID 08806367080202

Full Covered metallic tracheal stent

M.I.Tech Co., Ltd.

Polymer-metal tracheal/bronchial stent

• Primary Device ID: 08806367080202
• NIH Device Record Key: 932aeff8-a584-45f8-a99b-7060f3b2ac45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Trachea/Bronchium(CCC)
• Version Model Number: TCS-16-060-090
• 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: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr
• Phone: +827043047474
• Email: jae@mitech.co.kr

Device Dimensions

• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 Millimeter
• Stent Length: 60 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 16 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806367080202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201342

FDA Product Code

• JCT: Prosthesis, Tracheal, Expandable

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: 2021-05-10
• Device Publish Date: 2021-04-30

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