Duns Number:036985604
Device Description: The HarmonyAIR G-Series HD Dual Lighthead G2, Non-Camera with Central Tandem is used with The HarmonyAIR G-Series HD Dual Lighthead G2, Non-Camera with Central Tandem is used with the HarmonyAIR G-Series Lighting System.
Catalog Number
LGH06CTVN
Brand Name
HarmonyAIR
Version/Model Number
G-Series 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)
Yes
Over the Counter (OTC)
-
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
9d9e6108-f71a-42ea-a846-07d162f0b2de
Public Version Date
September 01, 2022
Public Version Number
1
DI Record Publish Date
August 24, 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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |