Catalog Number

ED5013ST

Brand Name

Centurion

Version/Model Number

ED5013ST

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

OFD

Product Code Name

Catheter introducer kit

Public Device Record Key

7573922c-5477-4e68-aa53-bf9935dba2cf

Public Version Date

December 24, 2021

Public Version Number

1

DI Record Publish Date

December 16, 2021

Package DI Number

00653160349481

Quantity per Package

50

Contains DI Package

10653160349488

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE