OTSC Proctology 200.60

GUDID 04260206310266

OTSC Proctology is an innovative clipping system to be applied in proctology procedures • it is used for wall closure in the anorectum (e.g. fistulae) • offers three unique advantages: large volume of tissue secured | high stability at the lesion site | minimal strain on surrounding tissue • exceptional properties and therapeutic functions are based on its special design and material: superelastic Nitinol • material is biocompatible, can be applied as a long-term implant • absorbable U-shaped sutures or the OTSC Proctology Anchor may be used to place the applicator cap precisely on the lesion

Ovesco Endoscopy AG

Endoscopic manual linear stapler

• Primary Device ID: 04260206310266
• NIH Device Record Key: 178b8bca-9750-4d93-94bd-febc83f3da10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTSC Proctology
• Version Model Number: 14 t
• Catalog Number: 200.60
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150067

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: 4
• Public Version Date: 2019-10-31
• Device Publish Date: 2015-10-12

Devices Manufactured by Ovesco Endoscopy AG

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• 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
• 04260206311478 - BougieCap: 2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c