Catalog Number

ORVPLP02

Brand Name

Integrated Smoke Evacuation Pencil

Version/Model Number

ORVPLP02

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

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

80162126-dbbb-4f83-be00-abbbf67c5ea4

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 26, 2021

Package DI Number

30845854082069

Quantity per Package

20

Contains DI Package

10845854082065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX