DUROLANE

GUDID 08437027710001

DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

SAIMA GLOBAL FARMA S.L.

Synovial fluid supplementation medium

• Primary Device ID: 08437027710001
• NIH Device Record Key: f8e3daab-8ab4-4c9d-9c2a-f351fbe96b46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUROLANE
• Version Model Number: 1082020
• Company DUNS: 468910220
• Company Name: SAIMA GLOBAL FARMA S.L.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437027710001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170007

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: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by SAIMA GLOBAL FARMA S.L.

• 08437027710001 - DUROLANE: 2024-11-21DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
• 08437027710001 - DUROLANE: 2024-11-21 DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock
• 08437027710018 - MONOVISC: 2024-11-21 MONOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in th
• 08437027710025 - ORTHOVISC: 2024-11-21 ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in t
• 08437027710049 - SYNVISC ONE: 2024-11-21 SYNVISC ONE (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hya
• 08437027710056 - SYNVISC: 2024-11-21 SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluro