HANAROSTENT® Esophagus TTS(CCC)

GUDID 08806367088413

Full 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 ID08806367088413
NIH Device Record Keya4687e50-f4e6-40ad-8250-fe982ee9390f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® Esophagus TTS(CCC)
Version Model NumberECBA-20-060-230
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 Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length60 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
GS108806367088413 [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(CCC)]

08806367088598Full Covered metallic esophagus stent
08806367088581Full Covered metallic esophagus stent
08806367088574Full Covered metallic esophagus stent
08806367088567Full Covered metallic esophagus stent
08806367088550Full Covered metallic esophagus stent
08806367088543Full Covered metallic esophagus stent
08806367088536Full Covered metallic esophagus stent
08806367088529Full Covered metallic esophagus stent
08806367088512Full Covered metallic esophagus stent
08806367088505Full Covered metallic esophagus stent
08806367088499Full Covered metallic esophagus stent
08806367088482Full Covered metallic esophagus stent
08806367088475Full Covered metallic esophagus stent
08806367088468Full Covered metallic esophagus stent
08806367088451Full Covered metallic esophagus stent
08806367088444Full Covered metallic esophagus stent
08806367088437Full Covered metallic esophagus stent
08806367088420Full Covered metallic esophagus stent
08806367088413Full Covered metallic esophagus stent
08806367088406Full Covered metallic esophagus stent
08806367088390Full Covered metallic esophagus stent
08806367088383Full Covered metallic esophagus stent
08806367088376Full Covered metallic esophagus stent
08806367088369Full Covered metallic esophagus stent
08806367088352Full Covered metallic esophagus stent
08806367088345Full Covered metallic esophagus stent
08806367088338Full Covered metallic esophagus stent
08806367088321Full Covered metallic esophagus stent
08806367088314Full Covered metallic esophagus stent
08806367088307Full Covered metallic esophagus stent
08806367088291Full Covered metallic esophagus stent
08806367088284Full Covered metallic esophagus stent
08806367088277Full Covered metallic esophagus stent
08806367088260Full Covered metallic esophagus stent
08806367088253Full Covered metallic esophagus stent
08806367088246Full Covered metallic esophagus stent
08806367088239Full Covered metallic esophagus stent
08806367088222Full Covered metallic esophagus stent
08806367088215Full Covered metallic esophagus stent
08806367088208Full 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

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