FTRD System Set 200.70

GUDID 04260206310556

The FTRD System Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following instruments: FTRD System (application cap with preloaded clip and integrated HF snare) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD System use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD System)

Ovesco Endoscopy AG

Endoscopic electrosurgical full-thickness tissue biopsy/resection set Endoscopic electrosurgical full-thickness tissue biopsy/resection set

• Primary Device ID: 04260206310556
• NIH Device Record Key: a61e9cc9-16a5-41ab-a247-65fd17e7823a
• Commercial Distribution Discontinuation: 2019-06-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FTRD System Set
• Version Model Number: 14
• Catalog Number: 200.70
• 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

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

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310556 [Previous]
GS1	04260206311010 [Primary]

FDA Product Code

• OCZ: Endoscopic Grasping/Cutting Instrument, Non-Powered
• 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: 6
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-07-31

Devices Manufactured by Ovesco Endoscopy AG

• 04260206311263 - BARS Anchor silver: 2022-11-30 The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conj
• 04260206311270 - BARS Anchor black: 2022-11-30 The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conj
• 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