Catalog Number

ET316ST

Brand Name

Centurion

Version/Model Number

ET316ST

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

JZF

Product Code Name

TUBE, EAR SUCTION

Public Device Record Key

b51a7cbc-d3f7-4c01-bd37-d33ecb9ea81f

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 01, 2022

Package DI Number

10653160224006

Quantity per Package

25

Contains DI Package

00653160224009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE