Catalog Number

DS2C007

Brand Name

CPS DIRECT™

Version/Model Number

SLII

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 05, 2018

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

d41fca6e-1a46-463a-a184-28dad4c52c2b

Public Version Date

June 07, 2019

Public Version Number

5

DI Record Publish Date

March 19, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-