Catalog Number

-

Brand Name

M Battery

Version/Model Number

CI-5553-190

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P960058

Product Code

MCM

Product Code Name

Implant, Cochlear

Public Device Record Key

43b02915-f412-48d0-908b-4d484ea1dc30

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-