OTSC System Set 100.13

GUDID 04260206310112

The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • 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 Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 04260206310112
• NIH Device Record Key: 9b63a27c-12fa-46f5-8c88-77a9c7ad79ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTSC System Set
• Version Model Number: 14/6 a
• Catalog Number: 100.13
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101428

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-31
• Device Publish Date: 2015-09-18

On-Brand Devices [OTSC System Set]

• 04260206310334: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310327: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310310: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310303: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310136: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310129: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310112: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310105: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310099: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310082: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310075: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310068: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310051: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310044: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310037: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310020: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206310013: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a