Catalog Number

11167

Brand Name

TRUMPET

Version/Model Number

KIT FOR RECD MEASUREMENTS WITH LOUDSPEAKER FUNCTION

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)

Yes

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

1c07814a-0ea0-4241-991f-719e5a066100

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-