Catalog Number

-

Brand Name

SONNET EAS Control Unit white, SP

Version/Model Number

35079

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

P000025,P000025,P000025,P000025,P000025,P000025,P000025,P000025

Product Code

PGQ

Product Code Name

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Public Device Record Key

b096c7d9-725c-4a9a-bc7e-0cf6a1e46e56

Public Version Date

July 15, 2022

Public Version Number

3

DI Record Publish Date

June 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-