HANAROSTENT® Esophagus Asymmetric (CCC)

GUDID 08806367044495

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, 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 ID08806367044495
NIH Device Record Key3e080ab9-a428-4271-a24a-ade06ad49c43
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® Esophagus Asymmetric (CCC)
Version Model NumberECN20080-X070
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+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr
Phone+827043047414
Emailpaul@mitech.co.kr

Device Dimensions

Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 Millimeter
Device Size Text, specify0
Stent Diameter20 Millimeter
Stent Length80 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806367044495 [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 Date2022-01-10
Device Publish Date2021-12-31

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

08806367096029Full Covered metallic esophagus stent
08806367096012Full Covered metallic esophagus stent
08806367096005Full Covered metallic esophagus stent
08806367095992Full Covered metallic esophagus stent
08806367095985Full Covered metallic esophagus stent
08806367095978Full Covered metallic esophagus stent
08806367095961Full Covered metallic esophagus stent
08806367044778Full Covered metallic esophagus stent
08806367044761Full Covered metallic esophagus stent
08806367044754Full Covered metallic esophagus stent
08806367044747Full Covered metallic esophagus stent
08806367044730Full Covered metallic esophagus stent
08806367044723Full Covered metallic esophagus stent
08806367044716Full Covered metallic esophagus stent
08806367044709Full Covered metallic esophagus stent
08806367044563Full Covered metallic esophagus stent
08806367044556Full Covered metallic esophagus stent
08806367044549Full Covered metallic esophagus stent
08806367044532Full Covered metallic esophagus stent
08806367044525Full Covered metallic esophagus stent
08806367044518Full Covered metallic esophagus stent
08806367044501Full Covered metallic esophagus stent
08806367044495Full Covered metallic esophagus stent
08806367044440Full Covered metallic esophagus stent
08806367044433Full Covered metallic esophagus stent
08806367044426Full Covered metallic esophagus stent
08806367044419Full Covered metallic esophagus stent
08806367044402Full Covered metallic esophagus stent
08806367043351Full Covered metallic esophagus stent
08806367020376Full Covered metallic esophagus stent
08806367020369Full Covered metallic esophagus stent
08806367020352Full 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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