Duns Number:264205501
Device Description: "SYMBIOZ LED is a LED light source intended to be used by doctors during surgical endoscop "SYMBIOZ LED is a LED light source intended to be used by doctors during surgical endoscopyor diagnostic procedures. It is fitted with an electronic iris with fibre optic detection, an automatic thermal protection system, a powerful level memory and an «iris» mode to shut off the light emission."
Catalog Number
S_298_0002
Brand Name
COMEG MEDICAL
Version/Model Number
SOURCE LED SOPRO S298
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
-
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
NTN
Product Code Name
Led Light Source
Public Device Record Key
b2d76099-6f73-4f2b-93f7-6effb81e13da
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |