HANAROSTENT® FAST^TM Biliary (NNN)

GUDID 08806367073365

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

M.I.Tech Co., Ltd.

Bare-metal biliary stent
Primary Device ID08806367073365
NIH Device Record Key1e6b59cf-32cd-4cf5-b1ba-0be119020f04
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® FAST^TM Biliary (NNN)
Version Model NumberSHS-10-040-S180
Company DUNS688454359
Company NameM.I.Tech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr
Phone+827043047405
Emailandrew@mitech.co.kr

Device Dimensions

Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0
Stent Diameter10 Millimeter
Stent Length40 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806367073365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGECatheter, Biliary, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-08
Device Publish Date2019-03-18

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

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

Trademark Results [HANAROSTENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HANAROSTENT
HANAROSTENT
79343425 not registered Live/Pending
M.I.Tech Co.,Inc
2022-05-31
HANAROSTENT
HANAROSTENT
79078614 3903217 Live/Registered
M.I.Tech Co.,Inc
2009-09-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.