Catalog Number

-

Brand Name

MEDWS

Version/Model Number

4.18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2020

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

K132684

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

6a93a2eb-a707-43ac-a542-d962ccef9657

Public Version Date

July 03, 2020

Public Version Number

2

DI Record Publish Date

January 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-