Catalog Number

-

Brand Name

GE

Version/Model Number

GE333

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

faa99754-6c3c-46d6-b2d4-0857582b23ff

Public Version Date

April 02, 2019

Public Version Number

1

DI Record Publish Date

March 25, 2019

Package DI Number

20883489001829

Quantity per Package

6

Contains DI Package

00883489001825

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-