Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe FID185704
GUDID M71389122049663SAM1
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.
FIDIA FARMACEUTICI SPA
Synovial fluid supplementation medium| Primary Device ID | M71389122049663SAM1 |
| NIH Device Record Key | 452f19bf-4491-4777-ae73-24514dbe4f5b |
| Commercial Distribution Discontinuation | 2022-06-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe |
| Version Model Number | FID185704 |
| Catalog Number | FID185704 |
| Company DUNS | 428453013 |
| Company Name | FIDIA FARMACEUTICI SPA |
| Device Count | 2 |
| 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 | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@fidiapharma.us | |
| Phone | 866-749-2542 |
| customerservice@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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M71389122049663SAM0 [Unit of Use] |
| HIBCC | M71389122049663SAM1 [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 | 4 |
| Public Version Date | 2022-09-16 |
| Device Publish Date | 2017-02-12 |
Devices Manufactured by FIDIA FARMACEUTICI SPA
| 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 |
| 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 | 2022-10-04 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 | 2022-09-16HYMOVIS® 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. |
| 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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