Catalog Number

CVI4650B

Brand Name

Centurion

Version/Model Number

CVI4650B

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

62170ff7-bff1-42e4-bf5f-0913ba3f8e75

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Package DI Number

00653160347760

Quantity per Package

5

Contains DI Package

10653160347767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE