Catalog Number

-

Brand Name

Centurion

Version/Model Number

ECT18234SCST

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

adbc9d03-a317-48d8-881d-6beb263b2efd

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

June 30, 2017

Package DI Number

00653160277364

Quantity per Package

40

Contains DI Package

10653160277361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE