Catalog Number

6801771

Brand Name

VITROS

Version/Model Number

6801771

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

K042838

Product Code

JIT

Product Code Name

Calibrator, secondary

Public Device Record Key

ff9bc620-d244-4a0f-9a7a-21a80dbaedf4

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-