Catalog Number

4777

Brand Name

NikoSurg

Version/Model Number

4777

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

-

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

1f425fac-612d-4bee-a3d1-144878655d5c

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

March 19, 2018

Package DI Number

30853512006227

Quantity per Package

4

Contains DI Package

20853512006220

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cs