Catalog Number

197652

Brand Name

Contrast Set

Version/Model Number

197652

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

Yes

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

K982123,K982123

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

15276252-51ea-4770-a743-0f9cb45193e2

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

20886333208887

Quantity per Package

10

Contains DI Package

00886333208883

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box