Duns Number:264205501
Device Description: Light Source alone (without Box and accessories)"This 30 Watt LED light source has been es Light Source alone (without Box and accessories)"This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices 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
S81P / 998523
Brand Name
COMEG MEDICAL TECHNOLOGIES
Version/Model Number
SOPRO 281 LIGHT SOURCE
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
K103813
Product Code
FCW
Product Code Name
Light Source, Fiberoptic, Routine
Public Device Record Key
1eb0fe9f-548f-4e7b-ba3d-3ee372b6f807
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
July 16, 2019
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 |