Catalog Number

K9350202G

Brand Name

Nexxis OR

Version/Model Number

MNA-420

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

K173381

Product Code

DXJ

Product Code Name

DISPLAY, CATHODE-RAY TUBE, MEDICAL

Public Device Record Key

80f2393c-abb4-43ce-b246-a5bca8755b63

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-