CRE™ RX

GUDID 08714729965411

Biliary Balloon Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter, non-medicated
Primary Device ID08714729965411
NIH Device Record Keyf40d89a4-4554-4d7f-b263-3d2c72963c27
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRE™ RX
Version Model NumberM00558860
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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 Datefalse
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
GS108714729965411 [Primary]

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 Number3
Public Version Date2024-12-23
Device Publish Date2017-10-31

On-Brand Devices [CRE™ RX]

08714729965497Biliary Balloon Dilatation Catheter
08714729965480Biliary Balloon Dilatation Catheter
08714729965473Biliary Balloon Dilatation Catheter
08714729965466Biliary Balloon Dilatation Catheter
08714729965459Biliary Balloon Dilatation Catheter
08714729965442Biliary Balloon Dilatation Catheter
08714729965435Biliary Balloon Dilatation Catheter
08714729965428Biliary Balloon Dilatation Catheter
08714729965411Biliary Balloon Dilatation Catheter

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