Duns Number:431082693
Device Description: Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist -Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD
Catalog Number
VR401111-1ND
Brand Name
HELION
Version/Model Number
116001
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
e847b62f-3da6-4aae-aaf0-1978db21110f
Public Version Date
February 18, 2022
Public Version Number
1
DI Record Publish Date
February 10, 2022
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. | 14 |