HANAROSTENT® FAST^TM Biliary (NNN)

GUDID 08806367082053

Un-covered self-expanding nitinol biliary stent with Short guidewire system

M.I.Tech Co., Ltd.

Bare-metal biliary stent

• Primary Device ID: 08806367082053
• NIH Device Record Key: deb09728-1772-4891-8a02-84338b88483f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® FAST^TM Biliary (NNN)
• Version Model Number: SHS-10-120-S180
• 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

Device Dimensions

• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 10 Millimeter
• Stent Length: 120 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806367082053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183396

FDA Product Code

• FGE: Catheter, Biliary, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-08
• Device Publish Date: 2019-03-18

On-Brand Devices [HANAROSTENT® FAST^TM Biliary (NNN)]

• 08806367082053: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367082046: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367082039: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367082022: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073747: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073730: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073723: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073716: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073709: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073693: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073396: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073389: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073372: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073365: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073358: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073341: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073334: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367073327: Un-covered self-expanding nitinol biliary stent with Short guidewire system