Duns Number:315304071
Device Description: LIGHT SOURCE LED GREEN For fluorescence imaging with ICG dye, With 2 LED light sources, Q LIGHT SOURCE LED GREEN For fluorescence imaging with ICG dye, With 2 LED light sources, Quiet operation, Dialog function, compatible with core nova, WOLF light-cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 300x160x424mm
Catalog Number
5165002
Brand Name
ENDOLIGHT
Version/Model Number
5165002
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)
-
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
8a15bf75-00a5-45d3-bbbe-7e7ee1993817
Public Version Date
July 20, 2022
Public Version Number
1
DI Record Publish Date
July 12, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |