Catalog Number

-

Brand Name

ClearChest®

Version/Model Number

100104-000

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

e8b51f26-045e-4a2b-bdb6-4c1369c63284

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

September 10, 2016

Package DI Number

10841561102331

Quantity per Package

6

Contains DI Package

00841561102334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-