Catalog Number

9004821

Brand Name

Henry Schein

Version/Model Number

9004821

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

8be7e1ad-3b17-4c53-a4ee-34475376372d

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

10304040026813

Quantity per Package

50

Contains DI Package

00304040026816

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case