Catalog Number

K9300331B

Brand Name

Nio Color 2MP

Version/Model Number

MDNC-2123

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

K171812

Product Code

PGY

Product Code Name

Display, diagnostic radiology

Public Device Record Key

3d3aa3c1-5654-44b9-a1a4-81334b36e6e9

Public Version Date

May 06, 2019

Public Version Number

1

DI Record Publish Date

April 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-