HANAROSTENT® FAST^TM Biliary (NNN)

GUDID 08806367073327

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

M.I.Tech Co., Ltd.

Bare-metal biliary stent

• Primary Device ID: 08806367073327
• NIH Device Record Key: a8711e3d-550b-4135-b9d8-670d3ed84e5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® FAST^TM Biliary (NNN)
• Version Model Number: SHS-08-040-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: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 40 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	08806367073327 [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)]

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• 08806367082039: Un-covered self-expanding nitinol biliary stent with Short guidewire system
• 08806367082022: Un-covered self-expanding nitinol biliary stent with Short guidewire system
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• 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
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• 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