Duns Number:618214410
Device Description: LED Light Source, comparable to most 300w Xenon, with 4 port turret (ACMI, Wolf, Storz and LED Light Source, comparable to most 300w Xenon, with 4 port turret (ACMI, Wolf, Storz and Olympus) Color temperature:6500°K @ 75 CRI or 5600°K @ 92 CRI. Expected LED life of 30,000 hours
Catalog Number
LS-300LED
Brand Name
Hayden Medical
Version/Model Number
LS-300LED
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
8ddf50c3-a12f-48fa-b67a-7bf9db79c03a
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 |