Duns Number:264205501
Device Description: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis appli "This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medicalpractices of the following special fields: ent, gynecology, urology, veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal protection system and a power level memory."
Catalog Number
S_281_0001
Brand Name
COMEG MEDICAL
Version/Model Number
SOURCE LED SOPRO 281 ORL
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
K103813
Product Code
NTN
Product Code Name
Led Light Source
Public Device Record Key
e8cc90f4-9274-4402-9a63-8789d01e281b
Public Version Date
December 22, 2021
Public Version Number
5
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 |