Siemens - Siemens UNITY 3 WITH INSERTS - SIVANTOS, INC.

Duns Number:157412271

Device Description: Siemens UNITY 3 WITH INSERTS

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More Product Details

Catalog Number

10824331

Brand Name

Siemens

Version/Model Number

UNITY 3 WITH INSERTS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 05, 2017

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EWO

Product Code Name

Audiometer

Device Record Status

Public Device Record Key

9f8a8441-d507-42da-b9ad-97f69301842d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIVANTOS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1885
2 A medical device with a moderate to high risk that requires special controls. 5568