Catalog Number

-

Brand Name

PKS OMNI 5mm/33cm

Version/Model Number

970010PC

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

K081766,K081766

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

d40602c2-e1b1-4839-917d-47d5cba5905d

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

00821925011311

Quantity per Package

5

Contains DI Package

00821925038097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-