Vycor Viewsite Brain Access System with Alignment Clip

GUDID 00859261006197

THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) 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. There is also an Alignment Clip (AC) included separately in the packaging that may be optionally attached to aid in the centering of third-party instrumentation, specifically navigational and image guided system (“IGS”) pointers or probes (“pointer”). Each VBAS device allows for the gentle retraction of tissue, visualization of the surgical site and for the manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.

VYCOR MEDICAL, INC.

Neurosurgical retraction cannula

• Primary Device ID: 00859261006197
• NIH Device Record Key: 68682043-fd1d-403c-9883-63b833ed5d65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vycor Viewsite Brain Access System with Alignment Clip
• Version Model Number: TC211503AC
• Company DUNS: 002586317
• Company Name: VYCOR MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859261006197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202694

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-27
• Device Publish Date: 2021-05-19

On-Brand Devices [Vycor Viewsite Brain Access System with Alignment Clip]

• 00859261006258: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006241: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006234: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006227: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006210: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006203: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006197: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006180: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006173: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006166: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006159: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor
• 00859261006142: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor