Home GUDID 26932503523022 NA
Primary DI 26932503523022
Brand NA
Company Micro-Tech (Nanjing) Co., Ltd.
Model MBD-AM-BA-2
Catalog number MBD-AM-BA-2
Device description the balloon diameter is 6-7-8mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide
Published 2016-02-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FGE Catheter, Biliary, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 26932503523022 Package GS1 1 In Commercial Distribution 16932503523025 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 26932503523022 26932503523022 16932503523025 16932503523025
GMDN Terms# Term, Definition table Term Definition Oesophageal balloon catheter A long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Balloon Length 55 Millimeter
Regulatory Flags# DUNS number 530269083 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06932503563857 Additional Working Channel EZS01175 2026-09-30 06932503563864 Additional Working Channel EZS11475 2026-09-30 06932503563871 Additional Working Channel EZS21780 2026-09-30 06932503516563 Sphincterotome / short-wire compatible RDSP-0230-231-2 2026-06-27 06932503540353 Disposable Biopsy Forceps 100575 100575 2020-03-23 06932503540360 Disposable Biopsy Forceps 100576 100576 2020-03-23 06932503540377 Disposable Biopsy Forceps 100577 100577 2020-03-23 06932503540384 Disposable Biopsy Forceps 100578 100578 2020-03-23 06932503510219 Pulmonary Hydro-Slide Guidewire GW-35/18 2026-05-29 06932503510226 Pulmonary Hydro-Slide Guidewire GW-35/26 2026-05-29 06932503563772 eyeMAX(TM) Single-use Video Pancreaticobiliary Scope CDS22009 2026-05-15 06932503516112 Sphincterotome / short-wire compatible RDSP-0525-121-1 2026-05-08 06932503516129 Sphincterotome / short-wire compatible RDSP-0525-221-1 2026-05-08 06932503516136 Sphincterotome / short-wire compatible RDSP-0525-131-1 2026-05-08 06932503516143 Sphincterotome / short-wire compatible RDSP-0525-231-1 2026-05-08 06932503516150 Sphincterotome / short-wire compatible RDSP-0530-111-1 2026-05-08 06932503516167 Sphincterotome / short-wire compatible RDSP-0530-211-1 2026-05-08 06932503516174 Sphincterotome / short-wire compatible RDSP-0530-121-1 2026-05-08 06932503516181 Sphincterotome / short-wire compatible RDSP-0530-221-1 2026-05-08 06932503516198 Sphincterotome / short-wire compatible RDSP-0530-131-1 2026-05-08
Other Devices Sharing Product Codes# 
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