Catalog Number

Z544552

Brand Name

Cochlear™ Standard Rechargeable Battery Module

Version/Model Number

Z544552

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P970051

Product Code

MCM

Product Code Name

IMPLANT, COCHLEAR

Public Device Record Key

158da855-9b9e-443e-a5b5-ea91dffddb7c

Public Version Date

August 30, 2021

Public Version Number

4

DI Record Publish Date

June 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-