Catalog Number

P1348428

Brand Name

Cochlear

Version/Model Number

P1348428

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191921

Product Code

PFO

Product Code Name

Active implantable bone conduction hearing system

Public Device Record Key

0b1f27e8-46d3-4b9a-be41-70c45ca6d63c

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-