BougieCap 400.32.02

GUDID 04260206310877

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

Ovesco Endoscopy AG

Endoscopic gastrointestinal stenosis dilator

• Primary Device ID: 04260206310877
• NIH Device Record Key: 8df585bd-cab9-4ced-a2b0-32028f7f2106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BougieCap
• Version Model Number: 14
• Catalog Number: 400.32.02
• 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: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com

Device Dimensions

• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28.8 Millimeter
• Outer Diameter: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310877 [Package]; Contains: 04260206310884; Package: folding box [3 Units]; In Commercial Distribution
GS1	04260206310884 [Primary]

FDA Product Code

• KNQ: Dilator, Esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-31
• Device Publish Date: 2018-10-05

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