Duns Number:839138955
Device Description: The device is designed to provide a specialized source of light for illumination of a site The device is designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It consists of an individual light head with more than one light source includes light-emitting diodes (LEDs) and a mechanism to adjust the focus. This device is portableand is 5 Watt powered.
Catalog Number
Solar 2010
Brand Name
AED Solar 2010 Portable LED Light Source
Version/Model Number
Solar 2010
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
-
Product Code
NTN
Product Code Name
Led Light Source
Public Device Record Key
db2c45a3-c4c1-4786-a7eb-2181a4e62261
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
March 06, 2020
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 | 579 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6418 |