DUROLANE 1082020

GUDID 00816986020808

DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.

BIOVENTUS LLC

Synovial fluid supplementation medium

• Primary Device ID: 00816986020808
• NIH Device Record Key: 0568a2f4-3e60-4c2f-9f28-d40c3695327d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUROLANE
• Version Model Number: 1082020
• Catalog Number: 1082020
• Company DUNS: 078450878
• Company Name: BIOVENTUS LLC
• 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: 800-836-4080
• Email: customerserviceUSA@bioventusglobal.com
• Phone: 800-836-4080
• Email: customerserviceUSA@bioventusglobal.com
• Phone: 800-836-4080
• Email: customerserviceUSA@bioventusglobal.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816986020808 [Primary]
GS1	10816986020805 [Package]; Package: Case [54 Units]; In Commercial Distribution
NDC/NHRIC	89130-2020-1 [Secondary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-20

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