Catalog Number

-

Brand Name

PenEvac1

Version/Model Number

ICM-000-0478

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

14dbd52e-feb0-4dd4-9b74-ed799438e9e2

Public Version Date

April 08, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

00817688020271

Quantity per Package

25

Contains DI Package

00817688020264

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-