Duns Number:556373053
Device Description: The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR I The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals.
Catalog Number
XQHLC1
Brand Name
HexaVue
Version/Model Number
HexaVue-SLC 1.0
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
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
fc368ef3-de9e-4e04-a10f-b540253e255b
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |