Catalog Number

-

Brand Name

NA

Version/Model Number

01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 20, 2020

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

1c78fca6-d4a0-4bfd-83be-eba29dcc32dd

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-