Duns Number:832211366
Device Description: The C-View® Lite System enables the interventional suite to utilize video integration from The C-View® Lite System enables the interventional suite to utilize video integration from multiple modality inputs.
Catalog Number
100500
Brand Name
C-View® Lite System
Version/Model Number
100500
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
K083321
Product Code
DXJ
Product Code Name
Display, Cathode-Ray Tube, Medical
Public Device Record Key
6c36c1c3-e99f-41ac-87c4-eed5186412b0
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
September 29, 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. | 5 |