remOVE DC Impulse 400.01

GUDID 04260206310563

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

Ovesco Endoscopy AG

Gastrointestinal endoscopic clip cutter generator

• Primary Device ID: 04260206310563
• NIH Device Record Key: 3990d312-7077-44fd-9c10-6d9bb2448b47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: remOVE DC Impulse
• Version Model Number: 400.01
• Catalog Number: 400.01
• Company DUNS: 344007369
• Company Name: Ovesco Endoscopy AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49707196528160
• Email: service@ovesco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160014

FDA Product Code

• QAG: Endoscopic Electrosurgical Clip Cutting System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-31
• Device Publish Date: 2018-01-18

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