Catalog Number

-

Brand Name

PenEvac1

Version/Model Number

ICM-000-0562

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

b3cbfe85-8d5f-4f26-b04e-66d51331ec9f

Public Version Date

April 08, 2019

Public Version Number

3

DI Record Publish Date

August 10, 2018

Package DI Number

00817688022459

Quantity per Package

20

Contains DI Package

00817688022428

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-