Duns Number:036985604
Device Description: The STERIS Sterile LightHandle Covers are designed for HarmonyAIR surgical lights, and pro The STERIS Sterile LightHandle Covers are designed for HarmonyAIR surgical lights, and provide sterile Control that allow for increasing and decreasing illumination through seven intensity Levels. They are compatible with all Harmony and HarmonyAIR Surgical Lights.
Catalog Number
LB53
Brand Name
NA
Version/Model Number
Sterile Lighthandle Cover
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"
Yes
For Single-Use
Yes
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
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
d5914e37-bba2-4e5f-9590-f18c77349fda
Public Version Date
January 27, 2021
Public Version Number
6
DI Record Publish Date
September 06, 2016
Package DI Number
50724995150131
Quantity per Package
4
Contains DI Package
10724995150133
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |