HANAROSTENT® Esophagus (NCN)

GUDID 08806367040688

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, 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 ID08806367040688
NIH Device Record Keya34c646b-1b3d-43b0-bca6-aa793251d7a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANAROSTENT® Esophagus (NCN)
Version Model NumberEPB18150-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 Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 Millimeter
Device Size Text, specify0
Stent Diameter18 Millimeter
Stent Length150 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
GS108806367040688 [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 (NCN)]

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08806367095930Partially Covered metallic esophagus stent
08806367095923Partially Covered metallic esophagus stent
08806367095916Partially Covered metallic esophagus stent
08806367095909Partially Covered metallic esophagus stent
08806367095893Partially Covered metallic esophagus stent
08806367095886Partially Covered metallic esophagus stent
08806367084224Partially Covered metallic esophagus stent
08806367073860Partially Covered metallic esophagus stent
08806367069177Partially Covered metallic esophagus stent
08806367040688Partially Covered metallic esophagus stent
08806367039781Partially Covered metallic esophagus stent
08806367039767Partially Covered metallic esophagus stent
08806367039750Partially Covered metallic esophagus stent
08806367039743Partially Covered metallic esophagus stent
08806367039736Partially Covered metallic esophagus stent
08806367039583Partially Covered metallic esophagus stent
08806367039576Partially Covered metallic esophagus stent
08806367039552Partially Covered metallic esophagus stent
08806367039545Partially Covered metallic esophagus stent
08806367039507Partially Covered metallic esophagus stent
08806367039491Partially Covered metallic esophagus stent
08806367039484Partially 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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