| Primary Device ID | M713FPRP400 |
| NIH Device Record Key | 81c97a9b-48e4-48ce-b47d-b4d81106f39d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RICHPLAT ORTHO 40 PRP SYSTEM |
| Version Model Number | FPRP40 |
| Catalog Number | FPRP40 |
| Company DUNS | 428453013 |
| Company Name | FIDIA FARMACEUTICI SPA |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us | |
| Phone | 973-577-6202 |
| regulatory@fidiapharma.us |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M713FPRP400 [Primary] |
| HIBCC | M713FPRP401 [Package] Package: case [10 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2025-10-31 |
| M713891220750010 - HYMOVIS® ONE 32mg/4ml syringe | 2025-12-15 HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, |
| M713FID075010 - HYMOVIS® ONE Professional Sample, 32mg/4ml syringe | 2025-12-15 HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, |
| M713FPRP400 - RICHPLAT ORTHO 40 PRP SYSTEM | 2025-12-15The RICHPLAT ORTHO® 40 Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. |
| M713FPRP400 - RICHPLAT ORTHO 40 PRP SYSTEM | 2025-12-15 The RICHPLAT ORTHO® 40 Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous plat |
| M713891220724200 - Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL | 2023-10-24 Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the |
| M713891220724120 - Hyalgan® Sodium Hyaluronate 2mL Vial | 2023-09-21 Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the kne |
| M713494290030100 - Hyalo4 Care Clear Hydrogel, 30g | 2023-06-22 Clear hydrogel wound dressing, 30g, Professional Sample |
| M713494290100350 - Hyalo4 Care Clear Hydrogel, 100g | 2023-06-22 Clear hydrogel wound dressing, 100g Tube |
| M713494440025080 - Hyalo4 Care Hydrogel, 25g | 2023-06-22 Hydrogel wound dressing, 25g, Professional Sample |