Screen, Leaded, Operator Radiation Protector
The STERIS Harmony rSheild is a radiation proton device with 23.6-inch tube mounts to the STERIS Lighting Visualization Systems.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Zhengzhou Henghao Optical Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 6 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | EAK |
| Device type | Screen, Leaded, Operator Radiation Protector |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2021-07-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| rShield | In distribution | |
| rShield | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aadco | Aadco Medical, Inc. | 101 |
| Kenex | Kenex (Electro-Medical) Ltd. | 69 |
| OT | Mavig Gmbh | 64 |
| Drape | Burlington Medical, LLC | 7 |
| Hercules Medium Duty Suspension System | Aadco Medical, Inc. | 5 |
| Porta Shield | Burlington Medical, LLC | 4 |
| Rampart | Rampart IC, Inc | 4 |
| Clear Lead Barrier | Biodex Medical Systems, Inc. | 3 |
| Techno-Aide | Techno-Aide, Inc. | 2 |
| Steradian Shield | Radux Devices Inc | 1 |
| ExoShield | Northstar Medical Radioisotopes, LLC | 1 |
| Rolling Radiation Shield | Alimed, LLC | 1 |
Showing 12 of 21. All products under Screen, Leaded, Operator Radiation Protector
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.