Catalog Number

CCU-0200

Brand Name

3NT Video Console 2

Version/Model Number

CCU-0200

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

d309f9ca-003c-4088-bf8e-7b1f441d8adc

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-