Catalog Number

2407-N

Brand Name

NikoSurg

Version/Model Number

2407-N

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

bdb3b2bd-ac02-41a0-b758-82d799cce781

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

October 05, 2018

Package DI Number

30853512006517

Quantity per Package

1200

Contains DI Package

10853512006513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case