Duns Number:080269345
Device Description: NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen p NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions).
Catalog Number
-
Brand Name
Overhead Tube Crane
Version/Model Number
XR5200
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
KPR
Product Code Name
System, X-Ray, Stationary
Public Device Record Key
a25e672a-bcbd-4037-9d1d-955470716016
Public Version Date
March 29, 2018
Public Version Number
2
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. | 44 |