Catalog Number

660RH

Brand Name

Proscope™

Version/Model Number

660RH

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

18ec2620-bc87-4216-a53c-de0c59eea5c9

Public Version Date

June 18, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

00634782524302

Quantity per Package

5

Contains DI Package

00634782824303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case