DEVICE: Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe (M71389122049663A16)
Device Identifier (DI) Information
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe
89122-0496-63
Not in Commercial Distribution
89122-0496-63
FIDIA FARMACEUTICI SPA
89122-0496-63
Not in Commercial Distribution
89122-0496-63
FIDIA FARMACEUTICI SPA
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44757 | Synovial fluid supplementation medium |
A sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MOZ | Acid, Hyaluronic, Intraarticular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P150010 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 3 Milliliter |
Device Record Status
9bda49c9-219c-45e9-bf97-2c6b771ddb9f
September 15, 2023
4
March 21, 2016
September 15, 2023
4
March 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
M71389122049663
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-749-2542
customerservice@fidiapharma.us
customerservice@fidiapharma.us