| Primary Device ID | 00815948020061 |
| NIH Device Record Key | 12b24dae-99d5-4640-ae59-602a4fff8976 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Systems Configuration |
| Version Model Number | ACE603DVELSYS-A |
| Company DUNS | 191077671 |
| Company Name | PENUMBRA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815948020061 [Primary] |
| NRY | Catheter, Thrombus Retriever |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2018-01-26 |
| 00815948024779 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 3 cm |
| 00815948024793 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 4 cm |
| 00815948029460 - REAL y-Series | 2024-04-24 REAL y-Series 2 |
| 00815948029477 - REAL y-Series | 2024-04-24 REAL y-Series 2 Eval |
| 00815948029484 - REAL y-Series | 2024-04-24 REAL y-Series GO |
| 00815948029507 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 5 cm |
| 00815948029514 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 6 cm |
| 00815948029521 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 7 cm |