Catalog Number

Not Applicable

Brand Name

MedSource Sprague Stethoscope

Version/Model Number

MS-STY

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

e9886480-e98d-4faa-935a-eb5be226a5c2

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Package DI Number

00816703027202

Quantity per Package

50

Contains DI Package

00816703027196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case