Catalog Number

CVI4650A

Brand Name

Centurion

Version/Model Number

CVI4650A

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OFD

Product Code Name

Catheter introducer kit

Public Device Record Key

64fa68a0-a197-45ee-af59-298bc71fe33e

Public Version Date

September 10, 2020

Public Version Number

1

DI Record Publish Date

September 02, 2020

Package DI Number

00653160344554

Quantity per Package

5

Contains DI Package

10653160344551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE