Catalog Number

8962540

Brand Name

VITROS

Version/Model Number

8962540

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

18c1bbab-6249-456f-ba2a-92d2ba57de01

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

-