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Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe FDA UDI
- Generic Name
- Synovial fluid supplementation medium FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 89122-4966-30 FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Catalog Number
- 89122-4966-30 FDA UDI
- Primary DI / UDI-DI
- M71389122496630A16 FDA UDI
- PMA Number
- P150010 FDA UDI
- FDA Product Code
- MOZ FDA UDI
- GMDN Term
- Synovial fluid supplementation medium FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe by Fidia Farmaceutici — Class III — FDA UDI — listed in FDA GUDID
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici
Sources (1)
- FDA UDI 4cc633be-3de0-452a-bed7-3b69561f988a 39 fields · synced May 30, 2026