remOVE DC Impulse

Basic Information

• Brand Name: remOVE DC Impulse
• Primary DI: 04260206310563
• Version / Model: 400.01
• Catalog Number: 400.01
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-18
• Public Version: 4
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: 3990d312-7077-44fd-9c10-6d9bb2448b47

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAG	Endoscopic Electrosurgical Clip Cutting System	Obstetrics/Gynecology	876.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61184	Gastrointestinal endoscopic clip cutter generator	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260206310563	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN160014	000