VBAS Extension Arm - Extension arm for use with the VYCOR Brain Access - DESIGN STANDARDS CORP.

Duns Number:069862878

Device Description: Extension arm for use with the VYCOR Brain Access System (VBAS)

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More Product Details

Catalog Number

VY1021-01

Brand Name

VBAS Extension Arm

Version/Model Number

VY1021-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GDJ

Product Code Name

Clamp, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

ce1b61a5-b030-41ca-aac1-6b08c940c60c

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2020

Additional Identifiers

Package DI Number

00850003228082

Quantity per Package

1

Contains DI Package

00850003228075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DESIGN STANDARDS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1