Duns Number:078375583
Device Description: Light, Surgical, consiting of one to three light heads or one to two light heads and monit Light, Surgical, consiting of one to three light heads or one to two light heads and monitor arm. One or two light heads may utilize a camera or one light head my utilize a camera with a monitor arm.
Catalog Number
-
Brand Name
Skytron DoVera
Version/Model Number
DM520
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
FSY
Product Code Name
Light, Surgical, Ceiling Mounted
Public Device Record Key
77c1522f-37a3-4c1a-9d16-e78ad0f3d880
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 01, 2018
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 | 747 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 265 |