Catalog Number

-

Brand Name

Peng's Multifunctional Operative Dissector(Electrosurgical Pencil)

Version/Model Number

2A-D608-SG0013

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

3fd7b619-55d2-4cf7-8753-4d9498530a43

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Package DI Number

16924274957857

Quantity per Package

10

Contains DI Package

06924274957850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-