Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS8009

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"

Yes

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

LDE

Product Code Name

Stethoscope, Manual

Public Device Record Key

3ab85d07-15b7-411f-a7f2-8a91eb6f9ad6

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10849027002973

Quantity per Package

100

Contains DI Package

00849027002976

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case