Home GUDID 04260206311454
BougieCap
Primary DI 04260206311454
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
OTC false
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 DM exempt false Premarket exempt true 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# 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