HILZO Esophageal stents

GUDID 08809468541078

BCM Co., Ltd.

Polymer-metal oesophageal stent
Primary Device ID08809468541078
NIH Device Record Key74f4ee89-0b4f-46c7-870d-f7cc98193c4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHILZO Esophageal stents
Version Model NumberEVP2015HC1
Company DUNS690134873
Company NameBCM 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108809468541078 [Primary]

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 Date2026-01-29
Device Publish Date2026-01-21

On-Brand Devices [HILZO Esophageal stents ]

08809468543102EVP2008HCS2
08809468543089EVP2006HCS2
08809423560168EVP2015HCS2
08809423560151EVP2012HCS2
08809423560144EVP2010HCS2
08800026632474EVP2015HUS2
08800026632443EVP2012HUS2
08800026632429EVP2010HUS2
08800026632405EVP2008HUS2
08800026632382EVP2006HUS2
08800026612803EVP1915FC2
08809468542167EVP2014HC2
08809468542150EVP2013HC2
08809468542136EVP2011HC2
08809468542112EVP2009HC2
08809468542105EVP2008HC2
08809468542099EVP2007HC2
08809468542082EVP2006HC2
08809468542075EVP1915HC2
08809468542068EVP1914HC2
08809468542051EVP1913HC2
08809468542044EVP1912HC2
08809468542037EVP1911HC2
08809468542020EVP1910HC2
08809468542013EVP1909HC2
08809468542006EVP1908HC2
08809468541993EVP1907HC2
08809468541986EVP1906HC2
08809468541979EVP1815HC2
08809468541962EVP1814HC2
08809468541955EVP1813HC2
08809468541948EVP1812HC2
08809468541931EVP1811HC2
08809468541924EVP1810HC2
08809468541917EVP1809HC2
08809468541900EVP1808HC2
08809468541894EVP1807HC2
08809468541887EVP1806HC2
08809468541078EVP2015HC1
08809468541061EVP2014HC1
08809468541054EVP2013HC1
08809468541047EVP2012HC1
08809468541030EVP2011HC1
08809468541023EVP2010HC1
08809468541016EVP2009HC1
08809468541009EVP2008HC1
08809468540996EVP2007HC1
08809468540989EVP2006HC1
08809468540972EVP1915HC1
08809468540965EVP1914HC1

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.