Catalog Number

10958838

Brand Name

Audio Service

Version/Model Number

S_ITE QUIX 12 G5 L BLK TBLU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 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

bb77163e-9f9c-40cb-a011-0c89d568aea2

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

April 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-