Duns Number:080654574
Device Description: A software system used with the Microsoft Kinect intended to be used to support repetitive
Catalog Number
-
Brand Name
SaeboVR
Version/Model Number
SaeboVR-1
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
LXJ
Product Code Name
System, Optical Position/Movement Recording
Public Device Record Key
7f8f8192-d2d0-4f8c-b24d-526227597301
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
June 01, 2017
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. | 1 |