HANAROSTENT® Biliary (NNN)

GUDID 08806367017420

Un-covered self-expanding nitinol biliary stent

M.I.Tech Co., Ltd.

Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent
Primary Device ID08806367017420
NIH Device Record Keyc37e8055-ecd8-4413-b5f6-2dfbcc5870b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® Biliary (NNN)
Version Model NumberSHS-10-080-060
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+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr
Phone+827043047450
Emailinae116@mitech.co.kr

Device Dimensions

Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter
Device Size Text, specify0
Length80 Millimeter
Lumen/Inner Diameter10 Millimeter

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
GS108806367017420 [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 Number4
Public Version Date2022-04-08
Device Publish Date2017-07-03

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

08806367047199Un-covered self-expanding nitinol biliary stent
08806367047182Un-covered self-expanding nitinol biliary stent
08806367047151Un-covered self-expanding nitinol biliary stent
08806367047144Un-covered self-expanding nitinol biliary stent
08806367047137Un-covered self-expanding nitinol biliary stent
08806367047120Un-covered self-expanding nitinol biliary stent
08806367047113Un-covered self-expanding nitinol biliary stent
08806367047106Un-covered self-expanding nitinol biliary stent
08806367047090Un-covered self-expanding nitinol biliary stent
08806367047083Un-covered self-expanding nitinol biliary stent
08806367047076Un-covered self-expanding nitinol biliary stent
08806367047069Un-covered self-expanding nitinol biliary stent
08806367047052Un-covered self-expanding nitinol biliary stent
08806367047045Un-covered self-expanding nitinol biliary stent
08806367047038Un-covered self-expanding nitinol biliary stent
08806367047021Un-covered self-expanding nitinol biliary stent
08806367017642Un-covered self-expanding nitinol biliary stent
08806367017628Un-covered self-expanding nitinol biliary stent
08806367017611Un-covered self-expanding nitinol biliary stent
08806367017604Un-covered self-expanding nitinol biliary stent
08806367017598Un-covered self-expanding nitinol biliary stent
08806367017581Un-covered self-expanding nitinol biliary stent
08806367017574Un-covered self-expanding nitinol biliary stent
08806367017567Un-covered self-expanding nitinol biliary stent
08806367017468Un-covered self-expanding nitinol biliary stent
08806367017444Un-covered self-expanding nitinol biliary stent
08806367017437Un-covered self-expanding nitinol biliary stent
08806367017420Un-covered self-expanding nitinol biliary stent
08806367017413Un-covered self-expanding nitinol biliary stent
08806367017406Un-covered self-expanding nitinol biliary stent
08806367017390Un-covered self-expanding nitinol biliary stent
08806367017383Un-covered self-expanding nitinol biliary stent

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

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