Catalog Number

9004824

Brand Name

Henry Schein

Version/Model Number

9004824

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)

-

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

67a2005a-73a3-4dca-a24b-9458a60aafaf

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

10304040026844

Quantity per Package

20

Contains DI Package

00304040026847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case