AccessGUDID - DEVICE: remOVE DC Impulse (04260206310563)

GUDID

Device Identifier (DI) Information

Brand Name: remOVE DC Impulse
Version or Model: 400.01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400.01
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310563
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QAG	Endoscopic Electrosurgical Clip Cutting System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160014	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3990d312-7077-44fd-9c10-6d9bb2448b47
Public Version Date: October 31, 2019
Public Version Number: 4
DI Record Publish Date: January 18, 2018