Catalog Number

-

Brand Name

DEFINA

Version/Model Number

EPK-3000-US

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172156

Product Code

PEA

Product Code Name

Endoscope, Accessories, Image Post-Processing For Color Enhancement

Public Device Record Key

a1c6acf5-9ca0-47c7-8fc8-31d27aa527a5

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

April 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-