Home GUDID M84937120
Flex-Ez Stylet Wire Balloon Dilator
Primary DI M84937120
Brand Flex-Ez Stylet Wire Balloon Dilator
Company HOBBS MEDICAL, INC.
Model 3712
Catalog number 3712
Device description A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Published 2016-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name KNQ Dilator, Esophageal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KNQ Dilator, Esophageal Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M84937120 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Gastrointestinal/biliary dilation balloon catheter, non-medicated A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Regulatory Flags# DUNS number 076769355 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M84921890 CleanCapture Aspiration Catheter 2189 2189 2026-01-14 M84921891 CleanCapture Aspiration Catheter 2189 2189 2026-01-14 M84960050 Hobbs Biliary Amsterdam Stent Kit 6005 6005 2016-09-21 M84960060 Hobbs Biliary Amsterdam Stent Kit 6006 6006 2016-09-21 M84960090 Hobbs Biliary Amsterdam Stent Kit 6009 6009 2016-09-21 M84960110 Hobbs Biliary Amsterdam Stent Kit 6011 6011 2016-09-21 M84960120 Hobbs Biliary Amsterdam Stent Kit 6012 6012 2016-09-21 M84960130 Hobbs Biliary Amsterdam Stent Kit 6013 6013 2016-09-21 M84960140 Hobbs Biliary Amsterdam Stent Kit 6014 6014 2016-09-21 M84960150 Hobbs Biliary Amsterdam Stent Kit 6015 6015 2016-09-21 M84963100 Freeman Pancreatic Flexi-Stent Kit 6310 6310 2016-09-21 M84963110 Freeman Pancreatic Flexi-Stent Kit 6311 6311 2016-09-21 M84963200 Freeman Pancreatic Flexi-Stent Kit 6320 6320 2016-09-21 M84963210 Freeman Pancreatic Flexi-Stent Kit 6321 6321 2016-09-21 M84965010 Freeman Pancreatic Flexi-Stent Kit 6501 6501 2016-09-21 M84965020 Freeman Pancreatic Flexi-Stent Kit 6502 6502 2016-09-21 M84965030 Freeman Pancreatic Flexi-Stent Kit 6503 6503 2016-09-21 M84965040 Freeman Pancreatic Flexi-Stent Kit 6504 6504 2016-09-21 M84965050 Freeman Pancreatic Flexi-Stent Kit 6505 6505 2016-09-21 M84965060 Freeman Pancreatic Flexi-Stent Kit 6506 6506 2016-09-21
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