Catalog Number

-

Brand Name

PKS NEEDLE 5mm, 33cm

Version/Model Number

PK-NE0533

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

K142154,K142154

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

3d3c948b-3f38-4782-9321-b20f3071fb1c

Public Version Date

July 29, 2019

Public Version Number

6

DI Record Publish Date

October 05, 2016

Package DI Number

00821925028135

Quantity per Package

5

Contains DI Package

00821925041790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-