Catalog Number

670BKH

Brand Name

Proscope™

Version/Model Number

670BKH

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

Yes

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

c7979bfd-438b-4ba9-9940-8a94ddefc11b

Public Version Date

June 05, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

00634782524418

Quantity per Package

5

Contains DI Package

00634782824419

Package Discontinue Date

May 23, 2018

Package Status

Not in Commercial Distribution

Package Type

Master Case