Catalog Number

P1487131

Brand Name

Cochlear™ Custom Sound® Suite

Version/Model Number

P1487131

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"

Yes

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

acff55c4-b865-4efb-82ca-017ae4b9710b

Public Version Date

September 10, 2021

Public Version Number

2

DI Record Publish Date

June 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-