HANAROSTENT® LowAxTM Colon/Rectum(NNN)

GUDID 08806367080752

Un-covered self-expanding nitinol colon stent

M.I.Tech Co., Ltd.

Bare-metal colonic stent
Primary Device ID08806367080752
NIH Device Record Key2c7bc222-1ed8-4398-bbcc-bf2a97ed5fc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® LowAxTM Colon/Rectum(NNN)
Version Model NumberCNJF-22-090-230
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+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com
Phone+821042945040
Emailskim@mitechglobal.com

Device Dimensions

Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 Millimeter
Length2300 Millimeter
Stent Length90 Millimeter
Stent Diameter22 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108806367080752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQRStent, Colonic, Metallic, Expandable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-05
Device Publish Date2019-02-18

On-Brand Devices [HANAROSTENT® LowAxTM Colon/Rectum(NNN)]

08806367080929Un-covered self-expanding nitinol colon stent
08806367080899Un-covered self-expanding nitinol colon stent
08806367080868Un-covered self-expanding nitinol colon stent
08806367080851Un-covered self-expanding nitinol colon stent
08806367080820Un-covered self-expanding nitinol colon stent
08806367080790Un-covered self-expanding nitinol colon stent
08806367080783Un-covered self-expanding nitinol colon stent
08806367080752Un-covered self-expanding nitinol colon stent
08806367080721Un-covered self-expanding nitinol colon stent
08806367080714Un-covered self-expanding nitinol colon stent
08806367080684Un-covered self-expanding nitinol colon stent
08806367080653Un-covered self-expanding nitinol colon stent
08806367080646Un-covered self-expanding nitinol colon stent
08806367080615Un-covered self-expanding nitinol colon stent
08806367080585Un-covered self-expanding nitinol colon stent
08806367080578Un-covered self-expanding nitinol colon stent
08806367080547Un-covered self-expanding nitinol colon stent
08806367080516Un-covered self-expanding nitinol colon 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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