Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield VH-6001

GUDID 00607567701335

The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.

MAQUET CARDIOVASCULAR LLC

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Primary Device ID00607567701335
NIH Device Record Key1f2efe7d-31f0-47db-a3fc-20e672f33ef1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield
Version Model NumberVH-6001
Catalog NumberVH-6001
Company DUNS022348156
Company NameMAQUET CARDIOVASCULAR LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100607567701335 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-29
Device Publish Date2024-05-21

Devices Manufactured by MAQUET CARDIOVASCULAR LLC

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