Duns Number:036985604
Device Description: The HarmonyAIR Mobile Stand with G-Series Lighthead with metal crate is designed to provid The HarmonyAIR Mobile Stand with G-Series Lighthead with metal crate is designed to provide a flexible, mobile lighting system for various surgical and diagnostic procedures in healthcare environments.
Catalog Number
LG0056
Brand Name
HarmonyAIR
Version/Model Number
G5 Mobile Surgical Light
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
FSS
Product Code Name
Light, surgical, floor standing
Public Device Record Key
0c07f556-9b45-414b-8c6f-c2601db9c1a8
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
May 19, 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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |