BARS Set 100.60

GUDID 04260206310983

The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Ovesco Endoscopy AG

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 04260206310983
• NIH Device Record Key: f52eb525-2137-4926-9e9c-0c3afc86d2b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BARS Set
• Version Model Number: BARS Set
• Catalog Number: 100.60
• Company DUNS: 344007369
• Company Name: Ovesco Endoscopy AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Balloon Length: 1800 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Length: 1850 Millimeter
• Balloon Diameter: 6 Millimeter
• Guidewire Length: 3700 Millimeter
• Guidewire Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241858

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

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: 2024-12-09
• Device Publish Date: 2024-11-29

Devices Manufactured by Ovesco Endoscopy AG

• 04260206310983 - BARS Set: 2024-12-09The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
• 04260206310983 - BARS Set: 2024-12-09 The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is bas
• 04260206311263 - BARS Anchor silver: 2022-11-30 The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conj
• 04260206311270 - BARS Anchor black: 2022-11-30 The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conj
• 04260206311379 - BougieCap: 2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
• 04260206311393 - BougieCap: 2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
• 04260206311416 - BougieCap: 2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
• 04260206311430 - BougieCap: 2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
• 04260206311454 - BougieCap: 2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c