Catalog Number

1384007

Brand Name

VITROS

Version/Model Number

1384007

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K903189

Product Code

DIF

Product Code Name

Drug mixture control materials

Public Device Record Key

e4c44825-6df6-4d05-8c1c-d7728d5c1eb4

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

April 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-