mini OTSC System Set 100.01

GUDID 04260206311102

The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • 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: 04260206311102
• NIH Device Record Key: ee72b990-2d51-4b11-a581-79f9a1a4c927
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mini OTSC System Set
• Version Model Number: 10/3 a
• Catalog Number: 100.01
• 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: false
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206311102 [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: 3
• Public Version Date: 2019-10-31
• Device Publish Date: 2018-10-10

On-Brand Devices [mini OTSC System Set]

• 04260206311119: The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same
• 04260206311102: The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same
• 04260206311249: The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same
• 04260206311232: The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same