remOVE DC Cutter Set - The remOVE DC Cutter Set 14 is part of the remOVE - Ovesco Endoscopy AG

Duns Number:344007369

Device Description: The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following pro The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes remOVE SecureCap 14 is an elastic and transparent retrieval cap for safe extraction of the clip fragments remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract

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


More Product Details

Catalog Number

400.02.02s

Brand Name

remOVE DC Cutter 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

Labeling does not contain MRI Safety Information

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

DEN160014

Product Code Details

Product Code

QAG

Product Code Name

Endoscopic Electrosurgical Clip Cutting System

Device Record Status

Public Device Record Key

0570ec45-79ec-420d-a36e-149551c18309

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

January 15, 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