FDA.reportPublic FDA data

Vycor Viewsite Brain Access System

Primary DI
00859261006111
Brand
Vycor Viewsite Brain Access System
Company
VYCOR MEDICAL, INC.
Model
TC282003
Device description
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.
Published
2017-06-21
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
K060973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060973000VYCOR SURGICAL ACCESS SYSTEMSVycor Medical, LLC2006-07-26GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859261006111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859261006111008592610061118592610061110859261006111

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial skin friction/moisture control fabric, single-patient reusableA non-sterile absorbent textile material intended to be applied in skin folds or where skin-to-skin contact occurs (e.g., armpits, under the breasts, stomach, groin, and between fingers or toes) to prevent or reduce skin-to-skin friction, moisture, and irritation/inflammation; it is not intended to be used on open wounds. It is made of natural and/or synthetic materials and contains an antimicrobial agent [e.g., silver (Ag)]. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859261006265VBAS Extension ArmVY1021-01VY1021-012026-07-27
00859261006159Vycor Viewsite Brain Access System with Alignment ClipTC282005AC2021-05-19
00859261006142Vycor Viewsite Brain Access System with Alignment ClipTC282007AC2021-05-19
00859261006166Vycor Viewsite Brain Access System with Alignment ClipTC282003AC2021-05-19
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776434458MillenniumAvalign Technologies, Inc.GZT2026-10-07
00190776434465MillenniumAvalign Technologies, Inc.GZT2026-10-07
00810220800591Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800607Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800614Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00190776420406MillenniumAvalign Technologies, Inc.GZT2026-08-26
00190776417239MillenniumAvalign Technologies, Inc.GZT2026-08-19
00190776416997MillenniumAvalign Technologies, Inc.GZT2026-08-18
00724995355296V. MuellerSteris CorporationGZT2026-08-18
00724995355319V. MuellerSteris CorporationGZT2026-08-18
00724995355340V. MuellerSteris CorporationGZT2026-08-18
00724995355364V. MuellerSteris CorporationGZT2026-08-18
00724995355388V. MuellerSteris CorporationGZT2026-08-18
00190776408756MillenniumAvalign Technologies, Inc.GZT2026-08-03
00190776402167MillenniumAvalign Technologies, Inc.GZT2026-07-21
00860003476802MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00860003476819MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00860003476826MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
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