Duns Number:689842626
Device Description: The EVS 3643 detector is an indirect conversion device in the form of a square plate in wh The EVS 3643 detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.
Catalog Number
-
Brand Name
Exprimer
Version/Model Number
EVS 3643
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
fa5e5ab2-784d-413b-b8d4-2111260779f0
Public Version Date
November 26, 2019
Public Version Number
7
DI Record Publish Date
September 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |