Catalog Number

023173-9045-3120-1720

Brand Name

audifon

Version/Model Number

rega XS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130514

Product Code

ESD

Product Code Name

Hearing Aid, Air Conduction

Public Device Record Key

a710f7eb-bef5-425f-9d60-c4017f2a6c63

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

May 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-