HYMOVIS® ONE Professional Sample, 32mg/4ml syringe FID07501
GUDID M713FID075010
HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
Synovial fluid supplementation medium| Primary Device ID | M713FID075010 |
| NIH Device Record Key | 98d4fb5a-0f63-43e9-b521-3d7ce969750c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYMOVIS® ONE Professional Sample, 32mg/4ml syringe |
| Version Model Number | FID07501 |
| Catalog Number | FID07501 |
| 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 | 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 |
Customer Support Contacts
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us | |
| Phone | 9735776202 |
| compliance@fidiapharma.us |
Device Dimensions
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M713FID075010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P150010
FDA Product Code
| MOZ | Acid, Hyaluronic, Intraarticular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2025-11-07 |
Devices Manufactured by FIDIA FARMACEUTICI SPA
| 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 | 2025-12-15HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack. |
| 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 | 2025-12-15 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 |
Trademark Results [HYMOVIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYMOVIS 79171133 4929840 Live/Registered |
FIDIA FARMACEUTICI S.p.A. 2015-04-20 |
 HYMOVIS 77896635 4148241 Live/Registered |
Fidia Farmaceutici SpA 2009-12-18 |
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