HANAROSTENT® FAST^TM Biliary (NNN) - Un-covered self-expanding nitinol biliary stent - M.I.Tech Co., Ltd.

Duns Number:688454359

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

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More Product Details

Catalog Number

-

Brand Name

HANAROSTENT® FAST^TM Biliary (NNN)

Version/Model Number

SHS-08-090-S180

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183396

Product Code Details

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Device Record Status

Public Device Record Key

cc01eb6e-34ae-49c2-9f70-33a6dc0f8f59

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

March 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"M.I.TECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 404