stentfix OTSC System Set 100.50

GUDID 04260206311706

The stentfix 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 the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant

Ovesco Endoscopy Usa, Inc.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 04260206311706
• NIH Device Record Key: 9b4258c8-9d5e-4acb-a082-bf8c90b4e9c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: stentfix OTSC System Set
• Version Model Number: stentfix
• Catalog Number: 100.50
• 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: 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
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206311706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183309

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: 2024-09-23
• Device Publish Date: 2024-09-13

Devices Manufactured by Ovesco Endoscopy Usa, Inc.

• 04260206311515 - mini OTSC System Set: 2024-09-23 The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System
• 04260206311522 - mini OTSC System Set: 2024-09-23 The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System
• 04260206311706 - stentfix OTSC System Set: 2024-09-23The stentfix 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 the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant
• 04260206311706 - stentfix OTSC System Set: 2024-09-23 The stentfix OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever •
• 04260206311539 - OTSC System Set: 2024-09-18 The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can b
• 04260206311546 - OTSC System Set: 2024-09-18 The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can b
• 04260206311553 - OTSC System Set: 2024-09-18 The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can b
• 04260206311560 - OTSC System Set: 2024-09-18 The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can b
• 04260206311577 - OTSC System Set: 2024-09-18 The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can b