Catalog Number

E 01 1430

Brand Name

VirtuEye

Version/Model Number

v2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K211291

Product Code

PGW

Product Code Name

Ear, Nose, And Throat Stereotaxic Instrument

Public Device Record Key

1880c865-60c5-4a6d-88d7-fa7607c14966

Public Version Date

October 25, 2022

Public Version Number

3

DI Record Publish Date

January 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-