Catalog Number

CTL-DIFM-05KY

Brand Name

LW Scientific

Version/Model Number

CTL-DIFM-05KY

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GLG

Product Code Name

Platelet Counting, Manual

Public Device Record Key

d3d835c7-4b7e-4a2a-b443-2e38bab2339c

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

January 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-