Catalog Number

-

Brand Name

NICO meniGLIDE

Version/Model Number

NN-8040

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Public Device Record Key

88325915-9da4-4275-8b1b-b0670d853d23

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

October 19, 2017

Package DI Number

10816744028401

Quantity per Package

5

Contains DI Package

00816744028404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-