Catalog Number

K9301649D

Brand Name

Nio Color 2MP LED

Version/Model Number

MDNC-2221

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

K133663

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

cad88a07-aee4-4d6c-8186-54e9209c197f

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-