Catalog Number

VS0591

Brand Name

Vortex Surgical

Version/Model Number

VS0591

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

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

OJK

Product Code Name

Eye tray

Public Device Record Key

c72c244b-30c0-46dc-a2c2-2c754a335707

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 07, 2021

Package DI Number

50749756354757

Quantity per Package

10

Contains DI Package

00749756354752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case