Catalog Number

-

Brand Name

4Klearity

Version/Model Number

4KR100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 2019

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

LMB

Product Code Name

Device, Digital Image Storage, Radiological

Public Device Record Key

a9a88c95-54ca-4cc1-85ef-2e2ab4625790

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

January 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-