| Primary Device ID | 00815948029736 |
| NIH Device Record Key | 2a365ac0-075b-4488-b340-c1f71c88e0df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swift Coil System |
| Version Model Number | SDH1-A |
| Company DUNS | 191077671 |
| Company Name | PENUMBRA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815948029736 [Primary] |
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-24 |
| Device Publish Date | 2024-04-16 |
| 00815948029736 | Swift Coil Detachment Handle |
| 00815948029729 | SwiftPAC Coil, 55 cm |
| 00815948029712 | SwiftPAC Coil, 50 cm |
| 00815948029705 | SwiftPAC Coil, 40 cm |
| 00815948029699 | SwiftPAC Coil, 35 cm |
| 00815948029682 | SwiftPAC Coil, 25 cm |
| 00815948029675 | SwiftPAC Coil, 20 cm |
| 00815948029668 | SwiftPAC Coil, 12 cm |
| 00815948029651 | SwiftPAC Coil, 9 cm |
| 00815948029644 | SwiftPAC Coil, 2 cm |
| 00815948029637 | SwiftPAC Coil, 1 cm |
| 00815948029583 | SwiftPAC Coil, 60 cm |
| 00815948029576 | SwiftPAC Coil, 45 cm |
| 00815948029569 | SwiftPAC Coil, 30 cm |
| 00815948029552 | SwiftPAC Coil, 15 cm |
| 00815948029545 | SwiftPAC Coil, 10 cm |
| 00815948029538 | SwiftPAC Coil, 8 cm |
| 00815948029521 | SwiftPAC Coil, 7 cm |
| 00815948029514 | SwiftPAC Coil, 6 cm |
| 00815948029507 | SwiftPAC Coil, 5 cm |
| 00815948024793 | SwiftPAC Coil, 4 cm |
| 00815948024779 | SwiftPAC Coil, 3 cm |