Duns Number:618214410
Device Description: LED 50W Solid State LED Light Source, comparable to most 175w halogen and 75w metal halide LED 50W Solid State LED Light Source, comparable to most 175w halogen and 75w metal halide light sources.Expected LED life of 50,000 hours..Color temperature: 6500°K nominal, with multi turret
Catalog Number
LS-200LED
Brand Name
Hayden Medical
Version/Model Number
LS-200LED
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
22db1d61-9925-4c8d-be84-27788d9a36fb
Public Version Date
August 11, 2022
Public Version Number
1
DI Record Publish Date
August 03, 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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |