Duns Number:315304071
Device Description: LIGHT SOURCE LED 1.3 76W LED, low operating noise level, dialog function, touch screen, c LIGHT SOURCE LED 1.3 76W LED, low operating noise level, dialog function, touch screen, color display, compatible with core, universal light cable connection, 6500K, U: 100-240VAC, 50/60Hz
Catalog Number
5162001
Brand Name
ENDOLIGHT
Version/Model Number
5162001
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
7a3974ba-fa7e-46e7-bd7f-f9a63870ad82
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
July 21, 2017
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 |