Home GUDID 04260206310907
BougieCap
Primary DI 04260206310907
Brand BougieCap
Company Ovesco Endoscopy AG
Model 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 • 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 2018-10-05
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 04260206310891 Package GS1 3 Not in Commercial Distribution 04260206310907 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260206310891 04260206310891 4260206310891 04260206310907 04260206310907 4260206310907
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 Length 33.8 Millimeter Outer Diameter 16 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 04260206311485 BougieCap Ovesco Endoscopy AG KNQ 2022-09-30 00884450383438 Elation 5™ Merit Medical Systems, Inc. KNQ 2022-08-25