HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)

GUDID 08806367081100

Un-covered self-expanding nitinol duodenum stent

M.I.Tech Co., Ltd.

Bare-metal duodenal stent
Primary Device ID08806367081100
NIH Device Record Key107d2898-c5dc-4092-9d5f-92e9bd2792f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)
Version Model NumberDNJF-20-090-140
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

Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 Millimeter
Stent Diameter20 Millimeter
Stent Length90 Millimeter
Length1400 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
GS108806367081100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUMStent, Metallic, Expandable, Duodenal

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 Duodenum/Pylorus(NNN)]

08806367081346Un-covered self-expanding nitinol duodenum stent
08806367081315Un-covered self-expanding nitinol duodenum stent
08806367081285Un-covered self-expanding nitinol duodenum stent
08806367081278Un-covered self-expanding nitinol duodenum stent
08806367081247Un-covered self-expanding nitinol duodenum stent
08806367081216Un-covered self-expanding nitinol duodenum stent
08806367081209Un-covered self-expanding nitinol duodenum stent
08806367081179Un-covered self-expanding nitinol duodenum stent
08806367081148Un-covered self-expanding nitinol duodenum stent
08806367081131Un-covered self-expanding nitinol duodenum stent
08806367081100Un-covered self-expanding nitinol duodenum stent
08806367081070Un-covered self-expanding nitinol duodenum 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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