Signison - BTE Wireless Hearing Aid, Bronze - INTRICON CORPORATION

Duns Number:002345767

Device Description: BTE Wireless Hearing Aid, Bronze

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


More Product Details

Catalog Number

93232-008

Brand Name

Signison

Version/Model Number

L155

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

OSM

Product Code Name

Hearing Aid, Air Conduction With Wireless Technology

Device Record Status

Public Device Record Key

487ca67a-1244-491c-bfb4-65335d6156d8

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTRICON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 64