Sonic - CV20 MNR T, 2.4G NFM DPB DG CAPTIVATE 20 - Sonic Innovations, Inc.

Duns Number:968696919

Device Description: CV20 MNR T, 2.4G NFM DPB DG CAPTIVATE 20

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Sonic

Version/Model Number

215347

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

OSM

Product Code Name

Hearing aid, air conduction with wireless technology

Device Record Status

Public Device Record Key

5a893d14-2d35-4140-b5d9-eafc8fc3b976

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

February 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONIC INNOVATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 92
2 A medical device with a moderate to high risk that requires special controls. 868