Catalog Number

CCS800/C

Brand Name

Merit Medical®

Version/Model Number

00884450400968

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

bba1c1d6-039a-4b41-a1a5-820913181baa

Public Version Date

September 21, 2020

Public Version Number

1

DI Record Publish Date

September 11, 2020

Package DI Number

10884450400965

Quantity per Package

25

Contains DI Package

00884450400968

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-