Catalog Number

-

Brand Name

DIB II Coil

Version/Model Number

04143

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

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

P000025,P000025,P000025

Product Code

MCM

Product Code Name

Implant, Cochlear

Public Device Record Key

8923d030-c08e-4adb-8fc9-358aab62328a

Public Version Date

May 19, 2022

Public Version Number

7

DI Record Publish Date

September 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-