Duns Number:036985604
Device Description: The Non-Sterilizable Plastic Light Handle is used with the HarmonyAIR A-Series Lighting Sy The Non-Sterilizable Plastic Light Handle is used with the HarmonyAIR A-Series Lighting System.
Catalog Number
LAS0038
Brand Name
HarmonyAIR
Version/Model Number
A-Series Non-Sterilizable Light Handle
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 18, 2021
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
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
da4f2b27-eaa0-46f2-a373-f5bc7dca7fb1
Public Version Date
May 18, 2021
Public Version Number
4
DI Record Publish Date
May 28, 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 |