Silicone Biliary Stent

GUDID 00684995500020

BENTEC MEDICAL OPCO, LLC

Biliary drainage catheter
Primary Device ID00684995500020
NIH Device Record Key6d6b1994-e527-458d-a549-eb4db58f374f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Biliary Stent
Version Model NumberGR83064-01
Company DUNS080524654
Company NameBENTEC MEDICAL OPCO, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100684995500020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGECatheter, Biliary, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-10
Device Publish Date2017-01-03

On-Brand Devices [Silicone Biliary Stent]

00684995500204GR83064-056SP
00684995500198GR83064-26SP
00684995500181GR83064-20SP
00684995500174GR83064-13SP
00684995500167GR83064-10SP
00684995500150GR83064-07SP
00684995500143GR83064-04SP
00684995500136GR83064-02SP
00684995500129GR83064-11
00684995500112GR83064-14
00684995500105GR83064-13
00684995500099GR83064-10
00684995500082GR83064-07
00684995500075GR83064-06
00684995500068GR83064-08
00684995500051GR83064-05
00684995500044GR83064-04
00684995500037GR83064-02
00684995500020GR83064-01
00684995500013GR83064-03
00684995500006GR83064-12

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