Catalog Number

-

Brand Name

PKS Macro Jaw Forceps 5mm/45cm

Version/Model Number

3640PK

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 21, 2017

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

K031078,K031078

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

62c9c092-bcce-4cdd-84a8-ff6daae3e0a4

Public Version Date

August 03, 2022

Public Version Number

5

DI Record Publish Date

October 03, 2016

Package DI Number

00821925009370

Quantity per Package

5

Contains DI Package

00821925041714

Package Discontinue Date

March 21, 2017

Package Status

Not in Commercial Distribution

Package Type

-