FDA.reportPublic FDA data

remOVE DC Impulse

Primary DI
04260206310563
Brand
remOVE DC Impulse
Company
Ovesco Endoscopy AG
Model
400.01
Catalog number
400.01
Device description
The remOVE DC Impulse Generator is part of the remOVE System and is a medical electrical device for fragmentation of OTSC and FTRD clips made by Ovesco Endoscopy AG for the digestive tract • design ensures a direct pulse only when sufficient contact with a segment of the clip is established • required accessories for operating the remOVE DC Impulse are: DC Impulse generator foot-activated switch with connector cable power cord DC cord in order to connect the DC Cutter (part of remOVE DC Cutter Set) • can only be used in combination with remOVE DC Cutter Set
Published
2018-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAGEndoscopic Electrosurgical Clip Cutting System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAGEndoscopic Electrosurgical Clip Cutting SystemObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160014000remOVE SystemOvesco Endoscopy AG2017-12-22QAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260206310563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206310563042602063105634260206310563

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip cutter generatorA portable, mains electricity (AC-powered) device intended to be used in conjunction with a cutter for the endoscopic removal of a gastrointestinal endoscopic clip. It is an electronic unit with controls (e.g., foot-switch) intended to generate a direct current (DC) for resistive heating, and subsequent cleavage of a previously implanted clip.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49707196528160service@ovesco.com
+19196519449customerservice@ovesco-usa.com

Regulatory Flags#

DUNS number
344007369
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260206311966BougieCap PP400.402026-01-16
04260206311911AWCduo124 cm200.57.052025-06-05
04260206311935AWCduo184 cm200.57.062025-06-05
04260206310983BARS SetBARS Set100.602024-11-29
04260206310648Traction Polypectomy Snare220 cm200.55.102016-09-16
04260206311010colonic FTRD Set14200.702018-05-28
04260206311027Coag Dissector165 cm200.502018-07-05
04260206311034AqaNife1.5 mm200.53.012018-10-02
04260206311041AqaNife2.0 mm200.53.022018-10-02
04260206311058AqaNife2.5 mm200.53.032018-10-02
04260206311065AqaNife3.0 mm200.53.042018-10-02
04260206311072diagnostic FTRD Set13200.762018-10-02
04260206311003LiftUpLiftUp200.56.012022-08-22
04260206311355LiftUp KitLiftUp Kit200.56.022022-08-22
04260206311263BARS Anchor silver165 cm200.122022-11-22
04260206311270BARS Anchor black165 cm200.132022-11-22
04260206310143OTSC Anchor165 cm200.102016-09-16
04260206310228OTSC Twin Grasper165 cm200.442016-09-16
04260206310235OTSC Twin Grasper220 cm200.452016-09-16
04260206310273OTSC Proctology Anchor38 cm200.612016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260206310938remOVE DC Cutter SetOvesco Endoscopy AGQAG2018-01-18
04260206310921remOVE DC Cutter SetOvesco Endoscopy AGQAG2018-01-15