Catalog Number

-

Brand Name

Amadé Hi, Terra Brown, Right

Version/Model Number

50463

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 29, 2017

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

P990052

Product Code

MPV

Product Code Name

Implant, Hearing, Active, Middle Ear, Partially Implanted

Public Device Record Key

5159ee50-a15e-4b99-9d0a-5ced2b93f8cb

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-