Catalog Number

-

Brand Name

OTOPro By Auditdata

Version/Model Number

OTOPro

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"

-

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

ETW

Product Code Name

Calibrator, Hearing Aid / Earphone And Analysis Systems

Public Device Record Key

230a01b9-1305-40e4-bf83-b16ad6e7d629

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-