Catalog Number

K12-06249C

Brand Name

Merit Medical®

Version/Model Number

10884450394837

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

4b2f7e3f-7658-4a67-96d2-fb111bd98634

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

October 12, 2018

Package DI Number

20884450394834

Quantity per Package

4

Contains DI Package

10884450394837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-