Catalog Number

-

Brand Name

Primus By Auditdata

Version/Model Number

2000 Primus Fitting Unit Pro

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 10, 2016

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)

-

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

a8e19569-5ad8-4df1-866d-4f8474864807

Public Version Date

July 08, 2019

Public Version Number

3

DI Record Publish Date

June 09, 2016

Package DI Number

57117810000996

Quantity per Package

1

Contains DI Package

57117810001054

Package Discontinue Date

June 10, 2016

Package Status

Not in Commercial Distribution

Package Type

-