Catalog Number

658OH

Brand Name

Adscope®

Version/Model Number

658OH

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

3b6efea6-6c2b-425c-9990-cc955b52313e

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

May 27, 2017

Package DI Number

00634782588311

Quantity per Package

3

Contains DI Package

00634782086886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case