Catalog Number

CCSB900/C

Brand Name

Merit Medical®

Version/Model Number

00884450401026

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

K163084,K163084,K163084

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Public Device Record Key

8aa5b9d3-546a-46df-9ff8-4046e65eb124

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

20884450401020

Quantity per Package

4

Contains DI Package

10884450401023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-