Duns Number:036985604
Device Description: The STERIS Harmony Surgical Lighting Visulization System cover and tray are a sterilizable The STERIS Harmony Surgical Lighting Visulization System cover and tray are a sterilizable consumable (disposable, single use) used to drape the light handle, camera housing, and flat screen monitor handles for the purpose of maintaining a sterile surgical environment.
Catalog Number
LB50
Brand Name
NA
Version/Model Number
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
c5a62562-b853-4de3-a31d-18c8bbdc10be
Public Version Date
April 12, 2021
Public Version Number
1
DI Record Publish Date
April 02, 2021
Package DI Number
50724995154214
Quantity per Package
2
Contains DI Package
20724995154213
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 |