CRE Fixed Wire

GUDID 08714729339298

Esophageal Balloon Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter, non-medicated
Primary Device ID08714729339298
NIH Device Record Key3c767b08-1875-446c-90d4-763def22c21f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRE Fixed Wire
Version Model NumberM00558360
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS108714729195986 [Primary]
GS108714729339298 [Package]
Contains: 08714729195986
Package: [5 Units]
In Commercial Distribution

FDA Product Code

KNQDilator, esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-12-23
Device Publish Date2016-09-24

On-Brand Devices [CRE Fixed Wire]

08714729339311Esophageal Balloon Dilatation Catheter
08714729202004Esophageal Balloon Dilatation Catheter
08714729201991Esophageal Balloon Dilatation Catheter
08714729201984Esophageal Balloon Dilatation Catheter
08714729339304Esophageal Balloon Dilatation Catheter
08714729339298Esophageal Balloon Dilatation Catheter

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