HYMOVIS® ONE 32mg/4ml syringe

Basic Information

• Brand Name: HYMOVIS® ONE 32mg/4ml syringe
• Primary DI: M713891220750010
• Version / Model: 89122-0750-01
• Catalog Number: 89122-0750-01
• Company Name: FIDIA FARMACEUTICI SPA
• Labeler DUNS: 428453013
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-07
• Public Version: 2
• Public Version Date: 2025-12-15
• Public Version Status: Update
• Public Device Record Key: 4b012ab3-049e-411d-abe7-3b462b039436

Device Description

HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE 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 single injection regimen. The product is packaged in a one syringe pack.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOZ	Acid, Hyaluronic, Intraarticular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M713891220750010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P150010	005

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius