Catalog Number

-

Brand Name

COFOE

Version/Model Number

CC10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 18, 2056

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

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

02a7893f-9c46-4af0-a267-81805938ce84

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-