Vycor Viewsite Brain Access System with Alignment Clip

Primary DI
00859261006166
Brand
Vycor Viewsite Brain Access System with Alignment Clip
Company
VYCOR MEDICAL, INC.
Model
TC282003AC
Device description
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.
Published
2021-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202694000Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.2021-01-14GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859261006166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859261006166008592610061668592610061660859261006166

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retraction cannulaA sterile single-lumen surgical device designed to be used with an obturator to atraumatically displace brain tissues without tissue penetration (e.g., careful insertion between gyri) to create a surgical access corridor to a specific lesion/abnormality within the brain. It is made of polymer materials and typically includes depth markings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002586317
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859261006159Vycor Viewsite Brain Access System with Alignment ClipTC282005AC2021-05-19
00859261006142Vycor Viewsite Brain Access System with Alignment ClipTC282007AC2021-05-19
00859261006173Vycor Viewsite Brain Access System with Alignment ClipTC211507AC2021-05-19
00859261006180Vycor Viewsite Brain Access System with Alignment ClipTC211505AC2021-05-19
00859261006197Vycor Viewsite Brain Access System with Alignment ClipTC211503AC2021-05-19
00859261006203Vycor Viewsite Brain Access System with Alignment ClipTC171107AC2021-05-19
00859261006210Vycor Viewsite Brain Access System with Alignment ClipTC171105AC2021-05-19
00859261006227Vycor Viewsite Brain Access System with Alignment ClipTC171103AC2021-05-19
00859261006234Vycor Viewsite Brain Access System with Alignment ClipTC120807AC2021-05-19
00859261006241Vycor Viewsite Brain Access System with Alignment ClipTC120805AC2021-05-19
00859261006258Vycor Viewsite Brain Access System with Alignment ClipTC120803AC2021-05-19
00859261006005Vycor Viewsite Brain Access SystemTC0604052017-06-21
00859261006012Vycor Viewsite Brain Access SystemTC0604072017-06-21
00859261006029Vycor Viewsite Brain Access SystemTC1208032017-06-21
00859261006036Vycor Viewsite Brain Access SystemTC1208052017-06-21
00859261006043Vycor Viewsite Brain Access SystemTC1208072017-06-21
00859261006067Vycor Viewsite Brain Access SystemTC1711052017-01-30
00859261006081Vycor Viewsite Brain Access SystemTC2115032017-06-21
00859261006098Vycor Viewsite Brain Access SystemTC2115052017-06-21
00859261006104Vycor Viewsite Brain Access SystemTC2115072017-06-21

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