Steradian Shield
Radiation Protection Shield
2manufacturers in China registered for this device type
1catalogue number
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 | Radux Devices Inc, United States |
|---|---|
| FDA product code | EAK |
| Device type | Screen, Leaded, Operator Radiation Protector |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-25 |
| Record revised | 2024-02-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner pack of 5 |
| Distribution end date | 2022-10-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SS0100 | Withdrawn |
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 |
| Screen, Leaded, Operator Radiation Protector | Steris Corporation | 2 |
| Techno-Aide | Techno-Aide, Inc. | 2 |
| 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.