Catalog Number

-

Brand Name

Peng's Multifunctional Operative Dissectors (Electrosurgical Pencil)

Version/Model Number

3810T

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040780,K040780

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

b8275a79-740c-406b-a74b-a8c6fdf82753

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

16924274957635

Quantity per Package

25

Contains DI Package

06924274957638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-