Duns Number:413819707
Device Description: Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch fl Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector.
Catalog Number
722222
Brand Name
Azurion
Version/Model Number
Azurion 3 M15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200917
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
18df31dd-6f89-404f-9742-12e91066fd9a
Public Version Date
June 03, 2020
Public Version Number
1
DI Record Publish Date
May 26, 2020
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. | 349 |