BougieCap

Basic Information

• Brand Name: BougieCap
• Primary DI: 04260206311485
• Version / Model: 17/18
• Catalog Number: 400.32.04
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 1
• Public Version Date: 2022-10-10
• Public Version Status: New
• Public Device Record Key: 93cebb5b-e81b-4a07-b3ec-98034773dec5

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNQ	Dilator, Esophageal	Gastroenterology, Urology	876.5365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62109	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260206311478	GS1		3	In Commercial Distribution
Primary	04260206311485	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Outer plateau diameters: 17 mm / 18 mm
Length	35.0	Millimeter
Device Size Text, specify			for endoscopes with diameter 9.4 - 9.9 mm
Device Size Text, specify			mounting depht of the cap: 9 mm