GN Hearing - HI,XB977-DWC,AGX8,WRM GRY - Gn Hearing A/S

Duns Number:306179227

Device Description: HI,XB977-DWC,AGX8,WRM GRY

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


More Product Details

Catalog Number

-

Brand Name

GN Hearing

Version/Model Number

22272771

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)

-

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

511e2bd0-b161-4c67-ae3c-386cac7402e9

Public Version Date

June 22, 2022

Public Version Number

1

DI Record Publish Date

June 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GN HEARING A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5301
2 A medical device with a moderate to high risk that requires special controls. 11227