| Primary Device ID | M748PL70 |
| NIH Device Record Key | 47c588b7-52ed-430e-ae17-5165bbda738b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers |
| Version Model Number | PL-7 |
| Company DUNS | 113577485 |
| Company Name | ISORAY MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | M748PL70 [Primary] |
| KXK | Source, Brachytherapy, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-03 |
| Device Publish Date | 2021-04-23 |