Catalog Number

10935984

Brand Name

Signia Siemens

Version/Model Number

HA ACE 5PX DRD

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 13, 2020

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

ESD

Product Code Name

Hearing Aid, Air Conduction

Public Device Record Key

ea01b48e-3288-4273-8fd1-bc047bfda821

Public Version Date

November 16, 2020

Public Version Number

4

DI Record Publish Date

June 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-