Duns Number:036985604
Device Description: The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the Harmo The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR E-Series Lighting System.
Catalog Number
LES14IN02
Brand Name
HarmonyAIR
Version/Model Number
E-Series Surgical Lighting System
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSY
Product Code Name
Light, surgical, ceiling mounted
Public Device Record Key
4b187a90-03bf-4002-a378-544606f6d4d3
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 26, 2021
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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |