Catalog Number

-

Brand Name

Digital flat panel detector

Version/Model Number

Venu1417P-PSI

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MQB

Product Code Name

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Public Device Record Key

f4f5da10-b724-4b10-8bcd-50668f49a8f9

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

06970569090085

Quantity per Package

1

Contains DI Package

06970569090023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-