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
M71389122049663A16
HIBCC
October 04, 2022
2
428453013 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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?
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MOZ Acid, Hyaluronic, Intraarticular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P150010 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 3 Milliliter
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Device Record Status

9bda49c9-219c-45e9-bf97-2c6b771ddb9f
September 15, 2023
4
March 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: M71389122049663 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
866-749-2542
customerservice@fidiapharma.us
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