Catalogue number 932527, listed by Alimed, LLC, United States, under Screen, Leaded, Operator Radiation Protector. 2 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Rolling Radiation Shield | Listed by | Alimed, LLC, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2024-02-19 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
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.