Catalog Number

323-16-2

Brand Name

NA

Version/Model Number

323-16-2

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

K890577,K890577

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Public Device Record Key

5e4d9b4f-e9ac-4ee7-a702-9e007caf6f09

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Package DI Number

30858512007090

Quantity per Package

6

Contains DI Package

10858512007096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box