Catalog Number

-

Brand Name

Visionflex

Version/Model Number

VFPROEX21.03

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OUG

Product Code Name

Medical Device Data System

Public Device Record Key

f8c7586d-c41e-4dd3-817a-cfcb0bdb672e

Public Version Date

August 25, 2020

Public Version Number

1

DI Record Publish Date

August 17, 2020

Package DI Number

09352527000768

Quantity per Package

1

Contains DI Package

09352527000614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box