BougieCap 400.32.03

GUDID 04260206311454

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

Ovesco Endoscopy AG

Endoscopic gastrointestinal stenosis dilator

• Primary Device ID: 04260206311454
• NIH Device Record Key: 61b2784d-cf40-46ac-9df0-f2cc14214687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BougieCap
• Version Model Number: 15/16
• Catalog Number: 400.32.03
• Company DUNS: 344007369
• Company Name: Ovesco Endoscopy AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +19196519449
• Email: customerservice@ovesco-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 32.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310907 [Previous]
GS1	04260206311454 [Package]; Contains: 04260206311461; Package: [3 Units]; In Commercial Distribution
GS1	04260206311461 [Primary]

FDA Product Code

• KNQ: Dilator, Esophageal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [BougieCap]

• 04260206310891: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206310877: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206310853: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206310839: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206310815: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206310792: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206311478: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206311454: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206311430: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206311416: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206311393: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
• 04260206311379: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp