Duns Number:036985604
Device Description: The STERIS Harmony rSheild is a radiation proton device with 31.5-inch tube mounts to the The STERIS Harmony rSheild is a radiation proton device with 31.5-inch tube mounts to the STERIS Lighting Visualization Systems.
Catalog Number
LB58
Brand Name
NA
Version/Model Number
rShield
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
EAK
Product Code Name
Screen, leaded, operator radiation protector
Public Device Record Key
24a08105-3df3-44fc-a5f0-44747ecf028c
Public Version Date
July 21, 2021
Public Version Number
2
DI Record Publish Date
March 31, 2021
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 |