Catalog Number

603-01N

Brand Name

Adscope®

Version/Model Number

603-01N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 2019

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

8b25bb95-15c4-4d8d-a02b-77e80331208d

Public Version Date

April 11, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

00634782841959

Quantity per Package

10

Contains DI Package

00634782042127

Package Discontinue Date

April 10, 2019

Package Status

Not in Commercial Distribution

Package Type

Inner Pack