Catalog Number

19206-006

Brand Name

Vidar Systems Corporation

Version/Model Number

MASTER CD, CLINICAL EXPRESS 6.1 BUILD 15

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

LMA

Product Code Name

Digitizer, Image, Radiological

Public Device Record Key

2ba85bad-2494-4cf4-a3c6-6b3d1680a649

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-