Catalog Number

658BD

Brand Name

Adscope®

Version/Model Number

658BD

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

K162589,K162589

Product Code

DQD

Product Code Name

Stethoscope, Electronic

Public Device Record Key

7de39ef0-7adb-4306-a12b-5d1b61e5fb84

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 31, 2017

Package DI Number

00634782584672

Quantity per Package

3

Contains DI Package

00634782083298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case