Home GUDID 04260206311485 BougieCap
Primary DI 04260206311485
Brand BougieCap
Company Ovesco Endoscopy AG
Model 17/18
Catalog number 400.32.04
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 04260206311478 Package GS1 3 In Commercial Distribution 04260206311485 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206311478 04260206311478 4260206311478 04260206311485 04260206311485 4260206311485
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 35 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 10653405050865 CONMED Conmed Corporation KNQ 2026-03-24 46932503524016 Rapide(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524023 Rapide(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524030 Rapide(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524047 Rapide(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524054 Rapide(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524061 Rapide(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524078 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524085 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524092 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524108 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524122 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524146 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 46932503524153 ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. KNQ 2025-12-06 00724995244576 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244606 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244620 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244637 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244651 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244699 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244705 Lumiflex US Endoscopy KNQ 2025-06-03 00724995244712 Lumiflex US Endoscopy KNQ 2025-06-03 20653405050787 CONMED Conmed Corporation KNQ 2023-10-10 04260206311386 BougieCap Ovesco Endoscopy AG KNQ 2022-09-30 04260206311409 BougieCap Ovesco Endoscopy AG KNQ 2022-09-30 04260206311423 BougieCap Ovesco Endoscopy AG KNQ 2022-09-30 04260206311447 BougieCap Ovesco Endoscopy AG KNQ 2022-09-30 04260206311461 BougieCap Ovesco Endoscopy AG KNQ 2022-09-30 00884450383438 Elation 5™ Merit Medical Systems, Inc. KNQ 2022-08-25 00884450383445 Elation 5™ Merit Medical Systems, Inc. KNQ 2022-08-25