Catalog Number

-

Brand Name

Centurion

Version/Model Number

ECV8002ST

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

de61ea20-6e39-4d98-af8e-3b3af20d3a2f

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 30, 2016

Package DI Number

00653160294354

Quantity per Package

5

Contains DI Package

10653160294351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE