HANAROSTENT® Esophagus (CCC)

GUDID 08806367021823

Full Covered metallic esophagus stent

M.I.Tech Co., Ltd.

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 ID08806367021823
NIH Device Record Keycc6c3954-17e6-470c-8424-4d84f0610c14
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® Esophagus (CCC)
Version Model NumberHES-22-120-070
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

Device Dimensions

Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner Diameter22 Millimeter
Device Size Text, specify0
Length120 Millimeter
Lumen/Inner 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108806367021823 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-11-28
Device Publish Date2017-07-03

On-Brand Devices [HANAROSTENT® Esophagus (CCC)]

08806367095879Full Covered metallic esophagus stent
08806367095862Full Covered metallic esophagus stent
08806367095855Full Covered metallic esophagus stent
08806367095848Full Covered metallic esophagus stent
08806367095831Full Covered metallic esophagus stent
08806367095824Full Covered metallic esophagus stent
08806367095817Full Covered metallic esophagus stent
08806367095800Full Covered metallic esophagus stent
08806367095794Full Covered metallic esophagus stent
08806367095787Full Covered metallic esophagus stent
08806367095770Full Covered metallic esophagus stent
08806367095763Full Covered metallic esophagus stent
08806367095756Full Covered metallic esophagus stent
08806367095749Full Covered metallic esophagus stent
08806367095732Full Covered metallic esophagus stent
08806367095725Full Covered metallic esophagus stent
08806367095718Full Covered metallic esophagus stent
08806367095701Full Covered metallic esophagus stent
08806367095695Full Covered metallic esophagus stent
08806367095688Full Covered metallic esophagus stent
08806367095671Full Covered metallic esophagus stent
08806367095657Full Covered metallic esophagus stent
08806367095640Full Covered metallic esophagus stent
08806367095633Full Covered metallic esophagus stent
08806367058249Full Covered metallic esophagus stent
08806367046796Full Covered metallic esophagus stent
08806367040350Full Covered metallic esophagus stent
08806367024961Full Covered metallic esophagus stent
08806367024824Full Covered metallic esophagus stent
08806367024817Full Covered metallic esophagus stent
08806367024800Full Covered metallic esophagus stent
08806367024794Full Covered metallic esophagus stent
08806367021830Full Covered metallic esophagus stent
08806367021823Full Covered metallic esophagus stent
08806367021816Full Covered metallic esophagus stent
08806367004222Full Covered metallic esophagus stent
08806367004215Full Covered metallic esophagus stent
08806367004208Full Covered metallic esophagus stent
08806367004192Full Covered metallic esophagus stent
08806367004185Full Covered metallic esophagus stent
08806367004178Full Covered metallic esophagus stent
08806367004161Full Covered metallic esophagus stent
08806367004147Full Covered metallic esophagus stent
08806367004130HES-18-080-070

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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