Catalog Number

35071377

Brand Name

VMA-SKREEN

Version/Model Number

35071377

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2022

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

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

CDF

Product Code Name

Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

Public Device Record Key

eb3ffbfd-40ff-4f40-aa4f-c426940f3803

Public Version Date

January 11, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-