Catalog Number

-

Brand Name

Otoport/Otocheck Mini-Printer Battery Pack (supplied with system)

Version/Model Number

OMP-BATT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

23b266ec-edc6-4a0a-869b-884f6de46a9d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-