Catalog Number

65340

Brand Name

Centurion

Version/Model Number

65340

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

HRQ

Product Code Name

HEMOSTAT

Public Device Record Key

8f5eb4fb-60d3-43f8-a4e3-cc217a859a12

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

10653160038023

Quantity per Package

20

Contains DI Package

00653160038026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE