Duns Number:094586898
Device Description: LED Rover Disoposable, Non-Sterile Series
Catalog Number
-
Brand Name
Sunoptic Technologies
Version/Model Number
Rover Lightsource series
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
FCW
Product Code Name
Light Source, Fiberoptic, Routine
Public Device Record Key
ec60aad5-70f8-42ed-bbae-b85c9e9eaf06
Public Version Date
July 30, 2018
Public Version Number
1
DI Record Publish Date
June 27, 2018
Package DI Number
M678SLS10
Quantity per Package
10
Contains DI Package
M678SLS0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |