Catalog Number

CCU-0100

Brand Name

3NT Video Console

Version/Model Number

CCU-0100

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

K192305

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Public Device Record Key

a3c61d29-6883-43f4-af81-16e600a5ec54

Public Version Date

February 22, 2021

Public Version Number

2

DI Record Publish Date

May 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-