Baha - Cochlear Baha Remote Control 2, US - Cochlear Bone Anchored Solutions AB

Duns Number:559784736

Device Description: Cochlear Baha Remote Control 2, US

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


More Product Details

Catalog Number

94791

Brand Name

Baha

Version/Model Number

94791

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)

-

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

e21b03e8-e491-4d25-8af1-3270da47439c

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

April 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COCHLEAR BONE ANCHORED SOLUTIONS AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 276