Catalog Number

-

Brand Name

Centurion

Version/Model Number

NACL10ST3

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

3d214a92-0f2d-4684-8eae-369cf44308d6

Public Version Date

January 15, 2019

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

00653160243963

Quantity per Package

150

Contains DI Package

10653160243960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE