3 catalogue numbers from MMC-120, listed by Endoshape, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Medusa Multi-Coil | Listed by | Endoshape, Inc., United States |
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Record published | 2015-09-23 |
| Record revised | 2021-02-05 (version 3) |
Specifications
Specifications | MRI safety | MR Conditional |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -29 to 60 °C; Storage environment humidity 30 to 85 % RH; Handling environment temperature 10 to 30 °C |
| Distribution end date | 2017-04-30 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
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.