Exprimer - The EVS 4343 Detector is an indirect conversion - DRTECH Corporation

Duns Number:689842626

Device Description: The EVS 4343 Detector is an indirect conversion device in the form of a square plate in wh The EVS 4343 Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.

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More Product Details

Catalog Number

-

Brand Name

Exprimer

Version/Model Number

EVS 4343

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MQB

Product Code Name

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

Device Record Status

Public Device Record Key

895bd7f1-4836-4cf2-8355-17b3df9ba936

Public Version Date

November 26, 2019

Public Version Number

7

DI Record Publish Date

August 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRTECH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 28