Duns Number:688274778
Catalog Number
-
Brand Name
ViVIX-S with VXvue
Version/Model Number
FXRD-1717SA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
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
K122866
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
cbe3e3b1-b665-4efc-ab3c-62bbbb96477f
Public Version Date
January 01, 2020
Public Version Number
6
DI Record Publish Date
July 08, 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. | 23 |