Catalog Number

-

Brand Name

Scope HelpOR Pro

Version/Model Number

SHKPRO-02

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OCT

Product Code Name

Anti Fog Solution And Accessories, Endoscopy

Public Device Record Key

4cc9d329-d5b8-4826-9d32-d2b864df9a29

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

09349967001561

Quantity per Package

6

Contains DI Package

09349967001554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper