Vycor Viewsite Brain Access System

GUDID 00859261006135

THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.

VYCOR MEDICAL, INC.

Neurosurgical retraction cannula stabilization tool
Primary Device ID00859261006135
NIH Device Record Key149aee16-a13a-4dd0-b6f6-c2f8776cc308
Commercial Distribution StatusIn Commercial Distribution
Brand NameVycor Viewsite Brain Access System
Version Model NumberTC282007
Company DUNS002586317
Company NameVYCOR MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859261006135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZTRetractor, Self-Retaining, For Neurosurgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-06-21

On-Brand Devices [Vycor Viewsite Brain Access System]

00859261006135THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006128THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006111THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006104THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006098THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006081THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006074THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006067THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006050THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006043THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006036THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006029THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006012THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices
00859261006005THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices

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