Catalog Number

6802328

Brand Name

VITROS

Version/Model Number

6802328

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

K062123,K062165

Product Code

DIF

Product Code Name

Drug mixture control materials

Public Device Record Key

b34fbe41-bc45-4d0a-948e-6924fcf9f284

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-