Catalog Number

HD-101

Brand Name

DUROSCOPE

Version/Model Number

HD-101

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FWL

Product Code Name

Camera, Cine, Endoscopic, Without Audio

Public Device Record Key

1dd15bf1-1635-4a78-868b-1c2f5f558f22

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

February 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-