Catalog Number

-

Brand Name

VISIUSeye

Version/Model Number

VISIUSeye iMRI 1.5T A and 3TS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

FTY

Product Code Name

Tape, Measuring, Rulers And Calipers

Public Device Record Key

ef530e1f-e120-47b1-878c-a1f1658f0705

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

June 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-