Catalog Number

-

Brand Name

ClearChest®

Version/Model Number

100110-000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K051383,K051383

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Public Device Record Key

bd6657a2-b5a9-4d04-9c82-99a39b37b339

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

September 10, 2016

Package DI Number

10841561102379

Quantity per Package

6

Contains DI Package

00841561102372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-