Catalog Number

-

Brand Name

Centurion

Version/Model Number

CC5280

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

-

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

-

FDA Premarket Submission

-

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

dbde7cc9-c5e2-43c6-82b1-a90741f39ccd

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

20653160248634

Quantity per Package

40

Contains DI Package

10653160248637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE