| Primary Device ID | 00850060751127 |
| NIH Device Record Key | b43ae46e-8ecb-4e1c-ae12-c900d3d77410 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProGen PRP Eclipse |
| Version Model Number | P5PG019 |
| Company DUNS | 005677967 |
| Company Name | Bellus Medical, LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850060751103 [Primary] |
| GS1 | 00850060751127 [Package] Contains: 00850060751103 Package: Box [3 Units] In Commercial Distribution |
| GS1 | 10850060751124 [Package] Package: Shipper [6 Units] In Commercial Distribution |
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-05 |
| Device Publish Date | 2024-08-28 |
| 00850060751172 | 30mL Platelet Rich Plasma production device |
| 00850060751165 | 30mL Platelet Rich Plasma production device |
| 00850060751134 | 15mL Platelet Rich Plasma production device |
| 00850060751127 | 15 mL Platelet Rich Plasma production device |