HANAROSTENT® Esophagus TTS(NCN)

GUDID 08806367088697

Partially Covered metallic esophagus stent

M.I.Tech Co., Ltd.

Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent, sterile Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent
Primary Device ID08806367088697
NIH Device Record Key3ef19bc2-5eac-475c-a0d3-5655e8aebfa2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® Esophagus TTS(NCN)
Version Model NumberEPBA-18-100-230
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+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
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 Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length100 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
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
GS108806367088697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ESWProsthesis, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

On-Brand Devices [HANAROSTENT® Esophagus TTS(NCN)]

08806367088994Partially Covered metallic esophagus stent
08806367088987Partially Covered metallic esophagus stent
08806367088970Partially Covered metallic esophagus stent
08806367088963Partially Covered metallic esophagus stent
08806367088956Partially Covered metallic esophagus stent
08806367088949Partially Covered metallic esophagus stent
08806367088932Partially Covered metallic esophagus stent
08806367088925Partially Covered metallic esophagus stent
08806367088918Partially Covered metallic esophagus stent
08806367088901Partially Covered metallic esophagus stent
08806367088895Partially Covered metallic esophagus stent
08806367088888Partially Covered metallic esophagus stent
08806367088871Partially Covered metallic esophagus stent
08806367088864Partially Covered metallic esophagus stent
08806367088857Partially Covered metallic esophagus stent
08806367088840Partially Covered metallic esophagus stent
08806367088833Partially Covered metallic esophagus stent
08806367088826Partially Covered metallic esophagus stent
08806367088819Partially Covered metallic esophagus stent
08806367088802Partially Covered metallic esophagus stent
08806367088796Partially Covered metallic esophagus stent
08806367088789Partially Covered metallic esophagus stent
08806367088772Partially Covered metallic esophagus stent
08806367088765Partially Covered metallic esophagus stent
08806367088758Partially Covered metallic esophagus stent
08806367088741Partially Covered metallic esophagus stent
08806367088734Partially Covered metallic esophagus stent
08806367088727Partially Covered metallic esophagus stent
08806367088710Partially Covered metallic esophagus stent
08806367088703Partially Covered metallic esophagus stent
08806367088697Partially Covered metallic esophagus stent
08806367088680Partially Covered metallic esophagus stent
08806367088673Partially Covered metallic esophagus stent
08806367088666Partially Covered metallic esophagus stent
08806367088659Partially Covered metallic esophagus stent
08806367088642Partially Covered metallic esophagus stent
08806367088635Partially Covered metallic esophagus stent
08806367088628Partially Covered metallic esophagus stent
08806367088611Partially Covered metallic esophagus stent
08806367088604Partially Covered metallic esophagus 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

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