Catalog Number

657BK

Brand Name

Adscope®

Version/Model Number

657BK

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

K060321,K060321

Product Code

DQD

Product Code Name

Stethoscope, Electronic

Public Device Record Key

23794294-adbd-42ab-b330-1afa02715fdf

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 27, 2018

Package DI Number

00634782555238

Quantity per Package

3

Contains DI Package

00634782055455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case