Catalog Number

10823960

Brand Name

Siemens

Version/Model Number

UNITY 3 ITE PADDY

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 05, 2017

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"

-

For Single-Use

-

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

EWO

Product Code Name

Audiometer

Public Device Record Key

1dfc8e5f-5622-422a-9925-dca4b565945b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-