Catalog Number

1792357

Brand Name

VITROS

Version/Model Number

1792357

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

K042520,K043384

Product Code

DIF

Product Code Name

Drug mixture control materials

Public Device Record Key

dab8309e-44de-4dab-b9e0-43d6b84c17a1

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-