Catalog Number

99-0102-001

Brand Name

EARGO

Version/Model Number

99-0102-001

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

-

Product Code

ESD

Product Code Name

Hearing aid, air conduction

Public Device Record Key

8bfc3e8e-a92f-47d3-b18e-9d30ac5d84c7

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

January 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-