Catalog Number

P0019S

Brand Name

PMI

Version/Model Number

P0019S

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

39895600-6d90-4a58-a750-147de4115649

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

10812608020864

Quantity per Package

6

Contains DI Package

00812608020867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX