Catalog Number

-

Brand Name

Auria™ PowerCel™ Plus

Version/Model Number

CI-5540-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

439a7591-096a-4533-aac6-5cfcf59ac053

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-