Catalog Number

-

Brand Name

Joyhicare

Version/Model Number

HTD6101US

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)

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

75f4821f-2609-44e5-956e-22f9431f5885

Public Version Date

January 03, 2022

Public Version Number

1

DI Record Publish Date

December 24, 2021

Package DI Number

16970289035479

Quantity per Package

120

Contains DI Package

06970289035472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-