Catalog Number

-

Brand Name

Audioscan

Version/Model Number

Axiom

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

69e1b720-c2e6-41c5-82c6-e5956d9f2f55

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

B161AXIOM3

Quantity per Package

1

Contains DI Package

B161AXIOM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton