Home GUDID 04260206311461
BougieCap
Primary DI 04260206311461
Brand BougieCap
Company Ovesco Endoscopy AG
Model 15/16
Catalog number 400.32.03
Device description The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Published 2022-09-30
Public version status New
Distribution status 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 04260206311454 Package GS1 3 In Commercial Distribution 04260206310907 Previous GS1 0 04260206311461 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311454 04260206311454 4260206311454 04260206310907 04260206310907 4260206310907 04260206311461 04260206311461 4260206311461
GMDN Terms# Term, Definition table Term Definition Endoscopic gastrointestinal stenosis dilator A sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. It is made of transparent synthetic polymer material and is available in various forms (e.g., a slender hollow tube through which is passed the endoscope before introduction into the GI tract, or a tapered cap applied to the distal end of the endoscope); the dilator is advanced through the lesion site with direct visualization through the endoscope. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Length 32.5 Millimeter
Regulatory Flags# DUNS number 344007369 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06936937786646 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792364 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792371 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792388 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792395 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792401 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792418 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06936937792425 STERIS CleanGuide™ Jiangsu Grit Medical Technology Co., Ltd. KNQ 2026-07-17 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-06-18 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664926765 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664927038 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664927069 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664927090 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664927120 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664927403 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15 06959664927434 NA Hangzhou AGS MedTech Co., Ltd. KNQ 2026-04-15