Duns Number:413819707
Device Description: Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-inch f Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-inch flat detector and interface for an OR table
Catalog Number
722033
Brand Name
Allura Xper FD
Version/Model Number
Allura Xper FD10 OR Table
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
-
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
5a884fbb-36e4-4a0a-bdaf-02ff3816fe9d
Public Version Date
September 20, 2019
Public Version Number
5
DI Record Publish Date
September 24, 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. | 349 |