CRE Wireguided

GUDID 08714729339328

Esophageal/Pyloric Wireguided Balloon Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter, non-medicated
Primary Device ID08714729339328
NIH Device Record Key53900288-7e6e-4db8-a4d6-cdac9d756550
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRE Wireguided
Version Model NumberM00558390
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729339328 [Primary]

FDA Product Code

FDFColonoscope and accessories, flexible/rigid

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 Date2016-09-24

On-Brand Devices [CRE Wireguided]

08714729339434Esophageal/Colonic Wireguided Balloon Dilatation Catheter
08714729339427Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter
08714729339410Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter
08714729339403Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter
08714729339397Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter
08714729339380Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter
08714729339373Esophageal Wireguided Balloon Dilatation Catheter
08714729339366Esophageal/Pyloric Wireguided Balloon Dilatation Catheter
08714729339359Esophageal/Pyloric Wireguided Balloon Dilatation Catheter
08714729339342Esophageal/Pyloric Wireguided Balloon Dilatation Catheter
08714729339335Esophageal/Pyloric Wireguided Balloon Dilatation Catheter
08714729339328Esophageal/Pyloric Wireguided Balloon Dilatation Catheter

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.