Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack 89122-0496-01
GUDID M713891220496010
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® 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 two injections given at weekly intervals. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium| Primary Device ID | M713891220496010 |
| NIH Device Record Key | 5bd665ff-6615-4381-910a-3af1c1b1ca18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack |
| Version Model Number | 89122-0496-01 |
| Catalog Number | 89122-0496-01 |
| 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 |
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 |
| 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 |
| 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 | M713891220496010 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-04 |
| Device Publish Date | 2022-09-26 |
Devices Manufactured by FIDIA FARMACEUTICI SPA
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| 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 |
| M713494440100350 - Hyalo4 Care Hydrogel, 100g | 2023-06-22 Hydrogel wound dressing, 100g Tube |
| M713891220496010 - Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack | 2022-10-04HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® 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 two injections given at weekly intervals. The product is packaged in a one syringe pack. |
| M713891220496010 - Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack | 2022-10-04 HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and resi |
| M71389122049663SAM1 - Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe | 2022-09-16 HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and resi |
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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