Catalog Number

K9605022

Brand Name

Nexxis OR

Version/Model Number

Nexxis system

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

e2573fb8-db16-44b9-b7a7-72379e488792

Public Version Date

May 06, 2019

Public Version Number

1

DI Record Publish Date

April 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-