Catalog Number

-

Brand Name

NICO Myriad-LX

Version/Model Number

NN-1000

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

K191599

Product Code

OJG

Product Code Name

Neurological Tray

Public Device Record Key

21d55d2a-71f8-4e42-9d81-212a3922e8de

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

November 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-