Catalog Number

P542010

Brand Name

PRO ADVANTAGE

Version/Model Number

P542010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LDE

Product Code Name

Stethoscope, Manual

Public Device Record Key

8cd98f47-5830-48d3-9c7c-a18b508cce27

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Package DI Number

M22P5420105

Quantity per Package

50

Contains DI Package

M220P5420103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-