OTSC System Set 100.31

GUDID 04260206311690

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 Usa, Inc.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 04260206311690
• NIH Device Record Key: 3eeea712-0fe7-4ce8-b023-f8c8f0548a2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTSC System Set
• Version Model Number: 12/6 t - 220
• Catalog Number: 100.31
• Company DUNS: 969139760
• Company Name: Ovesco Endoscopy Usa, Inc.
• 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: false
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206311690 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-18
• Device Publish Date: 2024-09-10

On-Brand Devices [OTSC System Set]

• 04260206311690: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311683: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311676: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311669: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311652: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311645: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311638: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311621: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311614: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311607: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311591: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311584: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311577: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311560: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311553: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311546: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a
• 04260206311539: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a