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

Duns Number:344007369

Device Description: The colonic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resecti The colonic FTRD 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 three instruments: colonic FTRD (application cap with preloaded clip and integrated HF snare endoscope sleeve, hand wheel and thread retriever for colonoscopes) • FTRD Marking Probe (HF coagulation probe marking of the target lesion in preparation of FTRD 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)

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More Product Details

Catalog Number

200.70

Brand Name

colonic FTRD Set

Version/Model Number

14

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

bae97a45-e9d3-4aac-abd8-b8c157bafb0a

Public Version Date

February 06, 2020

Public Version Number

6

DI Record Publish Date

May 28, 2018

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