Audio Service - Audio Service S_ITE CROS QUIX G5 L BLK TBLU - SIVANTOS, INC.

Duns Number:157412271

Device Description: Audio Service S_ITE CROS QUIX G5 L BLK TBLU Hearing Aid

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More Product Details

Catalog Number

10960049

Brand Name

Audio Service

Version/Model Number

S_ITE CROS QUIX G5 L BLK TBLU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ESD

Product Code Name

Hearing Aid, Air Conduction

Device Record Status

Public Device Record Key

698427c1-0416-4447-b9f7-796bcdc5e7f5

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

April 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIVANTOS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1885
2 A medical device with a moderate to high risk that requires special controls. 5568