BougieCap 400.31.01

GUDID 04260206310792

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: 04260206310792
• NIH Device Record Key: 21eb7c03-74d4-4a50-8f48-9d0182c92e39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BougieCap
• Version Model Number: 7
• Catalog Number: 400.31.01
• 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
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7.1 Millimeter
• Length: 14.7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310792 [Package]; Contains: 04260206310808; Package: folding box [3 Units]; In Commercial Distribution
GS1	04260206310808 [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

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• 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
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