Catalog Number

2507

Brand Name

NikoSurg

Version/Model Number

2507

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

3b2b30b7-f73c-4d5f-8982-3abd617df076

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

January 17, 2018

Package DI Number

20853512006589

Quantity per Package

50

Contains DI Package

10853512006582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bx