FTRD System Set - The FTRD System Set is a novel tool for - Ovesco Endoscopy AG

Duns Number:344007369

Device Description: The FTRD System Set is a novel tool for diagnostic and therapeutic full-thickness resectio 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)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

200.70

Brand Name

FTRD System Set

Version/Model Number

14

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FDI

Product Code Name

Snare, Flexible

Device Record Status

Public Device Record Key

a61e9cc9-16a5-41ab-a247-65fd17e7823a

Public Version Date

February 06, 2020

Public Version Number

6

DI Record Publish Date

July 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OVESCO ENDOSCOPY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 61