HANAROSTENT® Benefit™ Biliary (NNN)

GUDID 08806367093035

Un-covered self-expanding nitinol biliary stent

M.I.Tech Co., Ltd.

Bare-metal biliary stent

• Primary Device ID: 08806367093035
• NIH Device Record Key: e9425903-d68a-44b5-b882-1e537294f79a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANAROSTENT® Benefit™ Biliary (NNN)
• Version Model Number: BNHS-08-100-060
• 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
• 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
• 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
• 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: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Device Size Text, specify: 0
• Stent Diameter: 8 Millimeter
• Stent Length: 100 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
• 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	08806367093035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202973

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

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: 2021-09-08
• Device Publish Date: 2021-08-31

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

• 08806367093080: Un-covered self-expanding nitinol biliary stent
• 08806367093073: Un-covered self-expanding nitinol biliary stent
• 08806367093066: Un-covered self-expanding nitinol biliary stent
• 08806367093059: Un-covered self-expanding nitinol biliary stent
• 08806367093042: Un-covered self-expanding nitinol biliary stent
• 08806367093035: Un-covered self-expanding nitinol biliary stent
• 08806367093028: Un-covered self-expanding nitinol biliary stent
• 08806367093011: Un-covered self-expanding nitinol biliary stent
• 08806367093004: Un-covered self-expanding nitinol biliary stent
• 08806367092991: Un-covered self-expanding nitinol biliary stent
• 08806367092984: Un-covered self-expanding nitinol biliary stent
• 08806367092977: Un-covered self-expanding nitinol biliary stent
• 08806367092960: Un-covered self-expanding nitinol biliary stent
• 08806367092953: Un-covered self-expanding nitinol biliary stent
• 08806367092946: Un-covered self-expanding nitinol biliary stent
• 08806367092939: Un-covered self-expanding nitinol biliary stent
• 08806367092922: Un-covered self-expanding nitinol biliary stent
• 08806367092915: Un-covered self-expanding nitinol biliary stent
• 08806367092908: Un-covered self-expanding nitinol biliary stent
• 08806367092892: Un-covered self-expanding nitinol biliary stent
• 08806367092885: Un-covered self-expanding nitinol biliary stent
• 08806367092878: Un-covered self-expanding nitinol biliary stent
• 08806367092861: Un-covered self-expanding nitinol biliary stent
• 08806367092854: Un-covered self-expanding nitinol biliary stent
• 08806367092847: Un-covered self-expanding nitinol biliary stent
• 08806367092830: Un-covered self-expanding nitinol biliary stent
• 08806367092823: Un-covered self-expanding nitinol biliary stent
• 08806367092816: Un-covered self-expanding nitinol biliary stent
• 08806367092809: Un-covered self-expanding nitinol biliary stent
• 08806367092793: Un-covered self-expanding nitinol biliary stent
• 08806367092786: Un-covered self-expanding nitinol biliary stent
• 08806367092779: Un-covered self-expanding nitinol biliary stent
• 08806367092762: Un-covered self-expanding nitinol biliary stent
• 08806367092755: Un-covered self-expanding nitinol biliary stent
• 08806367092748: Un-covered self-expanding nitinol biliary stent
• 08806367092731: Un-covered self-expanding nitinol biliary stent