Catalog Number

-

Brand Name

Peng’s Multifunctional Operative Dissector(PMOD)

Version/Model Number

ISEP1000

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,K040780

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

6806902d-cae7-4075-a250-32852cfbe35d

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

16924274957161

Quantity per Package

5

Contains DI Package

06924274957164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-