Catalog Number

-

Brand Name

NICO Myriad-LX

Version/Model Number

NN-9010

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

-

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

FSS

Product Code Name

Light, Surgical, Floor Standing

Public Device Record Key

0a4b0047-8f76-4788-9db3-8ab76477a1c4

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-