Catalog Number

4800

Brand Name

NikoSurg

Version/Model Number

4800

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

29bedeb2-893e-4502-aac9-c4b37bbe8ae1

Public Version Date

February 03, 2022

Public Version Number

3

DI Record Publish Date

May 24, 2019

Package DI Number

20853512006640

Quantity per Package

50

Contains DI Package

10853512006643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bx