Catalog Number

EVE3005

Brand Name

NA

Version/Model Number

EVE3005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 17, 2019

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"

Yes

For Single-Use

Yes

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

K012598

Product Code

NUJ

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Public Device Record Key

fb0ce92c-b0b8-4e93-b484-0ae6df7e8b79

Public Version Date

April 17, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-