Catalog Number

P1631251

Brand Name

Osia® 2 Sound Processor Magnet Pack (strength 1), 1 pc

Version/Model Number

Osia 2 System

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

10c0db81-6b45-49b5-ae09-f2000afe2336

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-