Catalog Number

641BKKIT2

Brand Name

Adscope®

Version/Model Number

641BKKIT2

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

397c504b-443c-4842-9d30-e93485824890

Public Version Date

August 31, 2020

Public Version Number

1

DI Record Publish Date

August 22, 2020

Package DI Number

00634782599683

Quantity per Package

12

Contains DI Package

00634782098308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case