Catalog Number

2407

Brand Name

NIKO SURG

Version/Model Number

WR01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2018

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

6f86130f-70c6-449a-8b2c-fd3285df22c3

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

30853512006203

Quantity per Package

12

Contains DI Package

20853512006206

Package Discontinue Date

February 05, 2018

Package Status

Not in Commercial Distribution

Package Type

case