Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS8012

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

Yes

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

25e1d2fb-01da-4574-adc5-0a3205c228b9

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10849027002355

Quantity per Package

250

Contains DI Package

00849027002358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case