| Primary Device ID | 10884450408831 |
| NIH Device Record Key | ffc90f3d-4625-436e-9309-164a97561a8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Torpedo™ |
| Version Model Number | Initial Release |
| Catalog Number | TOR2520 |
| Company DUNS | 635091932 |
| Company Name | BIOSPHERE MEDICAL |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450408834 [Primary] |
| GS1 | 10884450408831 [Package] Contains: 00884450408834 Package: [5 Units] In Commercial Distribution |
| KRD | Device, Vascular, for Promoting 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 | 2026-01-23 |
| Device Publish Date | 2026-01-15 |
| 10884450408879 | Initial Release |
| 10884450408855 | Initial Release |
| 10884450408831 | Initial Release |
| 10884450408817 | Initial Release |