Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL 89122-0724-20

GUDID M713891220724200

Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles.

FIDIA FARMACEUTICI SPA

Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium

• Primary Device ID: M713891220724200
• NIH Device Record Key: 28617df5-15d5-4c95-ada5-0a06f9ada64d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
• Version Model Number: 89122-0724-20
• Catalog Number: 89122-0724-20
• Company DUNS: 428453013
• Company Name: FIDIA FARMACEUTICI SPA
• Device Count: 1
• 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: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store in original packaging (protected from light)
• Special Storage Condition, Specify: Between 0 and 0 *Store Below 77°F
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M713891220724200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950027

FDA Product Code

• MOZ: Acid, Hyaluronic, Intraarticular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL]

• M71389122072420A1: Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pai
• M713891220724200: Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pai