Catalog Number

-

Brand Name

NICO TRIOwand

Version/Model Number

NN-8028

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

K162075,K162075

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

c733467f-1297-4336-b1ed-14124f979bb5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

10816744028289

Quantity per Package

2

Contains DI Package

00816744028282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-