Catalog Number

-

Brand Name

VolparaDensity

Version/Model Number

3.4.2

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

K153427

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

8553a3be-ece4-486a-8ba9-8f97203905ce

Public Version Date

September 23, 2020

Public Version Number

3

DI Record Publish Date

August 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-