Catalog Number

-

Brand Name

Viz CTP

Version/Model Number

1.2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 20, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180161,K180161

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

da658807-0030-48b9-9675-61d8d7507c5c

Public Version Date

January 13, 2022

Public Version Number

3

DI Record Publish Date

April 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-