Catalog Number

12200

Brand Name

Partial Middle Ear Implant

Version/Model Number

12200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

K030492

Product Code

ETB

Product Code Name

Prosthesis, Partial Ossicular Replacement

Public Device Record Key

05daae09-ce02-4459-9c65-4fb10ee2e98c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-