Catalog Number

98960612681X

Brand Name

IntelliSpace Cardiovascular

Version/Model Number

4.1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153022

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

3ee7ba14-29d2-46d4-b6d0-1ae0e02cdf99

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-