Catalog Number

-

Brand Name

VIDEO PROCESSOR

Version/Model Number

EPK-I5010-BR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 20, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PEA

Product Code Name

Endoscope, Accessories, Image Post-Processing For Color Enhancement

Public Device Record Key

40b33bda-acfe-40fe-b9b0-c1b84c55a1fb

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

March 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-