Catalog Number

-

Brand Name

DEFINA

Version/Model Number

EPK-3000

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,K172156

Product Code

PEA

Product Code Name

Endoscope, accessories, image post-processing for color enhancement

Public Device Record Key

417c82e8-7b65-49ad-a0f3-6e9d92cff7fd

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-