BONASTENT® Esophageal

GUDID 08806369459068

Sewoon Medical Co., Ltd.

Polymer-metal oesophageal stent, sterile
Primary Device ID08806369459068
NIH Device Record Key3ee0bc54-8d13-47a3-9a68-0a62a1340987
Commercial Distribution StatusIn Commercial Distribution
Brand NameBONASTENT® Esophageal
Version Model NumberBE-1812
Company DUNS687784405
Company NameSewoon Medical 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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108806369459068 [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 Date2021-10-25
Device Publish Date2017-03-03

On-Brand Devices [BONASTENT® Esophageal]

08806369459105BE-1816
08806369459082BE-1814
08806369459068BE-1812
08806369459044BE-1810
08806369459020BE-1808
08806369459006BE-1806
08806369458603BER-1816
08806369458580BER-1814
08806369458566BER-1812
08806369458542BER-1810
08806369458528BER-1808
08806369458504BER-1806

Trademark Results [BONASTENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BONASTENT
BONASTENT
77603874 3791959 Live/Registered
SEWOON Medical Co., Ltd.
2008-10-30
BONASTENT
BONASTENT
77603874 3791959 Live/Registered
Standard Sci-Tech Inc.
2008-10-30
BONASTENT
BONASTENT
77536886 not registered Dead/Abandoned
EndoChoice, Inc.
2008-08-01

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