Catalog Number

28493

Brand Name

Biopor® AB

Version/Model Number

28493

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

ESD

Product Code Name

Hearing aid, air conduction

Public Device Record Key

ac4efab1-30e9-4f96-b79d-48c3f6dcdf2a

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-