EarCentric - Xiamen New Sound Technology Co., Ltd.

Duns Number:528181200

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More Product Details

Catalog Number

-

Brand Name

EarCentric

Version/Model Number

RIE 400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ESD

Product Code Name

Hearing Aid, Air Conduction

Device Record Status

Public Device Record Key

d224ce51-538d-4ab0-98b7-545bdd17ca78

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XIAMEN NEW SOUND TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 176
2 A medical device with a moderate to high risk that requires special controls. 43