Catalog Number

-

Brand Name

HD-Camera

Version/Model Number

HDC1500

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

K152109

Product Code

FET

Product Code Name

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Public Device Record Key

f0001aa5-27e8-4976-a4c7-1cd8c8cb3e7a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-