Catalog Number

K9300360B

Brand Name

Nio Color 5MP

Version/Model Number

MDNC-6121

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

K170476

Product Code

PGY

Product Code Name

Display, diagnostic radiology

Public Device Record Key

abf62955-5790-453d-af5b-29a1e2035700

Public Version Date

November 11, 2020

Public Version Number

1

DI Record Publish Date

November 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-