Catalog Number

609RKOI

Brand Name

Adscope®

Version/Model Number

609RKOI

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

015763fe-dc64-4026-a113-89ac00b07a9d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

Package DI Number

00843515000116

Quantity per Package

20

Contains DI Package

00843515234603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case