Catalog Number

619-01CHM

Brand Name

Adscope®

Version/Model Number

619-01CHM

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

-

Product Code

LDE

Product Code Name

Stethoscope, Manual

Public Device Record Key

4e34ac4d-e1c5-4bce-8032-7a78e7a8a0a4

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Package DI Number

00634782899509

Quantity per Package

10

Contains DI Package

00634782098124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack